The Dry Eye Digest
Volume II, Issue 2 - August 2006
Journal Roundup
NEW! In brief
Patient-friendly highlights of recently published studies
I had to blast through this month's abstracts in a hurry but I must say I enjoyed it more than anytime in recent memory! It was relatively light on intense 16-syllable laboratory science and instead included a very welcome infusion of articles on interactions, drug side effects, environmental-related studies and epidemiology. This kind of thing is immensely helpful in raising awareness of the life-impact of dry eye - y'know, patients as people, not just pairs of crackled corneas to douse with drugs now and then.
Here are some examples of articles I enjoyed this month:
- Ointment on the lid margins: A study in the American Journal of Ophthalmology studied benefits of basically lining the lid margins with ointment while at work in an attempt to counteract the problems posed for dry eyes by the office environment.
- Glaucoma and dry eye: A study in Cornea looked at how many patients with dry eye (ocular surface disease) suffer from glaucoma compared with those who do not have dry eyes. This is an important area as it should encourage more attention by eye doctors to the issues posed by having to manage dry eye and glaucoma at the same time. For example, people with dry eyes may be more vulnerable to harmful effects from preservatives in glaucoma medications.
- Rebamipide: The development of new dry eye drugs is excruciatingly slow, or at least seems so when you can't get enough relief from already available remedies. Those who have been following the progress of Rebamipide may be interested in this study in Cornea, which shows improvement to goblet cells, which are responsible for the mucin part of our tears and which for many of us are a key area of concern in anticipating new treatments. The peer review and publication cycle is slow - this report was submitted in early 2005 - but it will at least provide more information than has been available.
- Allergy & asthma meds and dry eye: A study in Current Allergy & Asthma Reports discusses the need for increased awareness of dry eye as a side effect of systemic medications, specifically antihistamines. Bravo!!! We need more vigilance in the medical community about this - along with blood pressure medications, acne medications and many more.
- "The modern office environment dessicates the eyes?" The title of this article in Indoor Air says it all! We liked this so much we wrote to congratulate the authors.
- 3-question dry eye survey: Although I think there are already some good dry eye surveys available that help quantify patient symptoms, which in turn helps patient-doctor communication, there is a need for something simpler that can be efficiently used for large-scale studies, and this one sounds like it may work. Now lets get on with the large-scale studies!
Study highlights
Acta Ophthalmologica Scandinavica
STARRY-EYED: The results in the abstract seem to get slightly lost amongst all the 'buts', but... I think they're saying that people with dry eyes have poorer contrast sensitivity and more disability glare than people with healthy eyes, but.... Contrast sensitivity and disability glare in patients with dry eye. Puell et al, 2006 Aug;84(4):527-31. Click here for abstract.
American Journal of Ophthalmology
MORE OF THE SAME (PRESUMABLY). And the more repetition in this area the better, say we. The incidence and risk factors for developing dry eye after myopic LASIK. Savini et al, 2006 Aug;142(2):355-6. Abstract not available online when we went to press.
GOOPING UP THOSE LIDS: This is an interesting one: Take an ointment and apply it all along the lid margin rather than in the eye. The claim of improved symptoms is easy to believe - we've known many patients who do this regularly. We've got our concerns about ointments in general though and we'd like to see more long-term studies of what they do to ocular surface wettability. Successful tear lipid layer treatment for refractory dry eye in office workers by low-dose lipid application on the full-length eyelid margin. Goto et al, Am J Ophthalmol. 2006 Aug;142(2):264-270.e1. Click here for abstract.
DOESN'T GET MUCH SIMPLER THAN THIS : A 3-question dry eye survey is apparently accurate enough for use in epidemiological studies. Now let's get cracking on those studies! Validation and repeatability of a short questionnaire for dry eye syndrome. Gulati et al, 2006 Jul;142(1):125-131. Click here for abstract.
Archivos de la Sociedad Espanola de Oftalmologia
INFOMERCIAL BREAK for Systane... at least that's what we assume this is (haven't read the full article as we don't have a subscription). [Reduction of corneal permeability in patients treated with HP-guar: a fluorophotometric study.] Cervan-Lopez et al, 2006 Jun;81(6):327-32. Click here for abstract.
Cornea
MORE GLAUCOMA WITH DRY EYE: Ha - we thought it was the other way around, since so many people on glaucoma meds seem to get ocular surface irritation from the preservatives. This is an interesting retrospective study at the University of Cincinnati. We couldn't agree more with the last sentence in the results stating that "This information warrants increased attention to treatment and management of OSD and concurrent glaucoma." Incidence and prevalence of glaucoma in severe ocular surface disease. Tsai et al, Cornea. 2006 Jun;25(5):530-2. Click here for abstract.
AND WHAT'S GOOD ENOUGH FOR RODENTS MUST BE GOOD ENOUGH FOR US: Or at least our goblet cells. This is a study on Rebamipide completed in 2005. Rebamipide is in Phase III clinicals at present and we are hoping they will get this one approved promptly. OPC-12759 increases proliferation of cultured rat conjunctival goblet cells. Rios et al, 2006 Jun;25(5):573-81. Click here for abstract.
Current Allergy and Asthma Reports
ABOUT THAT ANTIHISTAMINE, DOC: I was very happy to see this one, as a reminder that patients need to be made aware of the potential side effects of non-ocular drugs they are taking. Can't tell you how many times I've had site visitors who had no idea their allergy or blood pressure meds might be related to their dry eye woes. Ocular toxicity of systemic asthma and allergy treatments. L Bielory, 2006 Jul;6(4):299-305. Click here for abstract.
Graefe's Archive for Clinical and Experimental Ophthalmology
EPITHELIAL CELL DENSITIES AND SUCHLIKE: This study compares corneal thickness, epithelial cell density and other corneal properties in the central and peripheral cornea of 3 groups of patients (incl. aqueous deficient and some with lagophthalmos) versus controls. In vivo confocal laser scanning microscopy of the cornea in dry eye. Erdelyi et al, 2006 Jul 28; [Epub ahead of print]. Click here for abstract.
Indoor Air
AND ALL COMPUTER USERS SAID, AMEN: Well, perhaps the cynics amongst us muttered something more like "That'll be the day." Look at this: "The workplace, thermal conditions, and work schedule (including breaks) should be planned in such a way to help maintain a normal eye blink frequency to minimize alterations of the pre-corneal tear film." Yes, yes, yes! The modern office environment desiccates the eyes? Wolkoff et al, 2006 Aug;16(4):258-65. Click here for abstract.
Infection and Immunity
MORE DETECTIVE WORK: One of the latest in efforts to understand components of the tear film and where they do and don't reside, this discusses GP340. Nothing jumped off the page at me as hugely exciting but you never know when one of these might turn into a clue to an effective new treatment. Glycoprotein 340 in normal human ocular surface tissues and tear film. Jumblatt et al, 2006 Jul;74(7):4058-63. Click here for abstract.
Investigative Ophthalmology & Visual Science
ANOTHER ONE OF THOSE: Sigh, all the right names, again, and again I'd just like to see it in words of fewer than ten syllables because this kind of science is just way over my head without some attempt at translation into English. Will somebody somewhere develop a vision for making this stuff more accessible to the rest of us? Desiccating stress stimulates expression of matrix metalloproteinases by the corneal epithelium. Corrales et al, 2006 Aug;47(8):3293-302. Click here for abstract.
HOW TO TELL GOOD TEARS FROM BAD: Especially since you can't ask the rabbits (even New Zealand Whites - and by the by, I gotta love people who are precise enough to identify the make and model of the rabbits in their abstract). But returning to the point, there seem to be some type(s) of phospholipids present only in dry eye tears. Identification and comparison of the polar phospholipids in normal and dry eye rabbit tears by maldi-tof mass spectrometry. Ham et al, 2006 Aug;47(8):3330-8. Click here for abstract.
Journal of Biomedical Materials Research (Part B, Applied Biomaterials)
HMMM - DEFINITELY ONE TO WATCH: "As a therapeutic strategy, we are working to develop a bioengineered tear secretory system...." Tissue-engineered tear secretory system: Functional lacrimal gland acinar cells cultured on matrix protein-coated substrata. Selvam et al, 2006 Jul 18; [Epub ahead of print]. Click here for abstract.
Journal of Biomedical Optics
YES, THEY REALLY ARE DIFFERENT. It's hard to get excited about an abstract establishing that the tear film in dry eyes and lens wearers differs from controls - or about a last sentence stating that artificial tears apparently help. Interferometric measurements of dynamic changes of tear film. Szczesna et al, 2006 May-Jun;11(3):34028. Click here for abstract.
Journal of Cataract & Refractive Surgery
TOO OUTRAGED TO THINK UP A CATCHY BLURB: A study in this month's JCRS challenges the FDA's listing of auto-immune diseases as a contraindication to LASIK. Valid points are made that "not all auto-immune diseases are equal", and the authors openly acknowledge the limited scope of what they are attempting (establishing incidence of severe complications only - they did NOT review any data on visual outcomes or dry eye) but even as a preliminary step towards removing this contraindication this is of great concern to us. The overall gist and this section left me foaming at the mouth: "One limitation of our study is that we do not have data on the incidence or severity of dry eye or dry-eye complaints... LASIK is associated with dry eye signs and symptoms. The high incidence and variability of dry-eye symptoms after LASIK in normal eyes and the retrospective nature of our study would have made any conclusions about dry eye unreliable." Great. Just great. Let's keep the lawyers at bay by establishing that LASIK may be just tootin' fine for many auto-immune patients, on the basis that so many people get dry eye after LASIK anyway that we really don't have a clue if having RA, lupus or Sjogrens makes it worse. Laser in situ keratomileusis in patients with autoimmune diseases, Smith et al, JCRS 2006; 32:1292-1295. Click here for abstract.
Journal Francais d'Ophtalmologie
OBOY, A NEW DIAGNOSTIC TOY! (Uh, wassup with the pet name?) The Video Tearscope ("Vi-Te") sounds like a very interesting development in non-invasive tear film diagnostics. Hope to see more on this as the research progresses. The Video Tearscope: a new method for evaluating lacrimal film in vivo, Ounnoughene et al, J Fr Ophth 2006 May;29(5):476-84. Click here for abstract.
Journal of Rheumatology
ANOTHER MARKER FOR SJOGRENS? The cumulative numbers and 'respectivelys' in the abstract are a little dizzying but there are some interesting results here in identifying activation markers of Sjogrens Syndrome. Comparative analysis of autoantibodies against a-fodrin in serum, tear fluid, and saliva from patients with Sjogren's syndrome. Yavuz et al, 2006 Jul;33(7):1289-92. Click here for abstract.
Journal of Zhejiang University (Science, B)
YA THINK? Golly, I'm sure no one ever noticed THIS before: Steroids make dry eyes feel better pretty durned fast. Maybe in a few years someone will discover a connection between steroid use and IOP - if we're really lucky. A clinical study of the efficacy of topical corticosteroids on dry eye. Yang et al, 2006 Aug;7(8):675-8. Click here for abstract.
Klinika Oczna
YADA... ON SECOND THOUGHT, NADA of value added here. [The evaluation of tears secretion after refractive surgery] Mrukwa-Kominek et al, 2006;108(1-3):73-7. Click here for abstract (translated). Article in Polish.
Ophthalmologica
I COUNTED EVERYTHING EXCEPT THE NUMBERS: Gulp. Back to the drawing board, please. How can you possibly - or rather why on earth would you bother to - attempt to gauge the cost of treating dry eye syndrome while excluding the primary forms of both treatment (artificial tear supplementation) and care (self-care and optometrists)? Worse, how could you possibly come up with a set of criteria that would determine fewer than 0.1% of the population have dry eye, even if you were trying hard to get it wrong? Worst, when you know it's wrong and are happy to admit it, why bother publishing it? The annual cost of dry eye syndrome in France, Germany, Italy, Spain, Sweden and the United kingdom among patients managed by ophthalmologists. Clegg et al, 06 Aug;13(4):263-74. Click here for abstract.
What's in the Pipeline
On their way to pharmacies (sooner or later)?
ALLERGAN/OPTIF: According to the 8/4 quarterly investor conference call, this new artificial tear is due out this quarter. Click here for webcast & PDF transcript.
SINCLAIR PHARMA/SPHP700: Sinclair recently announced this was approved by the MHRA as Medical Device Class I (Sterile) and will be marketed as a prescription drug for the dry eye market. We're waiting for Sinclair to get back to us about the actual ingredients. From the limited information available it sounds like a glorified artificial tear, but maybe they will surprise us. Click here for a PDF copy of the full press release. Update 8/14: They are not releasing any more information about the mechanism of the drug and reportedly may not have it actually on the market for up to two years.
Teetering on the brink (of what, we don't know)
INSPIRE/"PROLACRIA" (DIQUAFOSOL TETRASODIUM): The most recent official news is as newsless as the last few rounds: "No substantive updates" was the characterization in the conference call on Aug 8th. Having twice fallen short of FDA blessings, hopefully by their next quarterly call we'll know whether we're looking at 'third time's a charm' or, um, 'three strikes and you're out biiiiiig bucks'. If the former, it sounds like they will go down the same path as Restasis with a co-promotion arrangement.
In Phase III Clinicals
OTSUKA-NOVARTIS/REBAMIPIDE: A study completed in 2005 was published this month in Cornea, which demostrated that it stimulates proliferation of conjunctival goblet cells in primary culture. Let's hope it works for humans and not just rats. Click here for abstract. Otherwise, no new news. Phase III clinical trials ongoing. This still seems to be the furthest along of anything in the current pipeline (unless Diquafosol/Prolacria surprises us) especially as androgen tears seem to have ground to a halt. Click here for initial screening checklist and list of study centers.
NOVAGALI/NOVA22007: (No updates this month) Cyclosporine emulsion. Recently started Phase III clinicals after obtaining new funding. Click here for most recent press release.
NASCENT/ iDESTRIN (NP50301): (No updates this month) Estrogen ester compound (topical eyedrop). Phase IIb clinical completed, now all we need is money to move forward. Latest report was in early January (click here for press release) stating good results from Phase IIb with "no drug related serious adverse effects". Click here for Nascent's page.
SENJU-ISTA/ECABET SODIUM: (No updates this month) Mucin secretagogue. Expecting to start Phase III trials in 2007, having reported positive results from Phase IIb studies in February 06. Ista claim that this is the first drug to show efficacy in clinicals against both signs and symptoms of dry eye. Click here for most recent press release and here for ISTA's main (albeit very outdated) page on this.
In Phase II clinicals
NOVARTIS / PIMECROLIMUS (AMS981): (No updates this month) Recruiting for Phase II clinicals. Click here for more info (or patients interested in signing up click here).
LANTIBIO/MOLI1901: (No updates this month)Cystic fibrosis drug being attempted as a dry eye treatment. Currently undergoing Phase II trials in the US following positive results in european Phase I studies. Click here for a, uh, colorful graphic about the mechanism of action.
On the horizon (maybe)
SENJU/LACRITIN: (No updates this month) It's very early stages yet but we've been keeping an eye on this for well over a year and think it's one of the most interesting and promising things coming down the pipeline. Some results of rabbit eye studies presented at ARVO recently. Click here for some updates & abstract from ARVO posted in Dry Eye Talk.
CAN-FITE/BIOPHARMA/CF-101: (No updates this month) CF101 is currently in clinical trials as a treatment for rheumatoid arthritis. The company has announced that it will shortly initiate another clinical study to test the drug's efficacy in treating dry eye symptoms. Click here for more.
OTHERA/OT-551: (No updates this month) This is in Phase II clinical for preventing cataracts in patients who have undergone vitrectomy. Othera has stated they expect to begin Phase II clinicals for two additional indications, AMD and dry eye syndrome, next year. Click here for more.
PAI-2: (No updates this month) Research being done at University of Pennsylvania and Temple University; data presented at ARVO recently. Not a whole lot of info but it sounds interesting. Click here for more.
Dead? In a coma? Dazed? Speak to me, baby
ALLERGAN/ANDROGEN TEARS: Frustration is mounting at the mixed signals about this. We heard that excellent data were presented at ARVO, and we heard that the study is progressing. On the other hand, from other sources we've heard that Allergan have all but given up on this. Indeed their total silence about androgen on their website and on their 2Q conference call on Aug. 4th are not promising. We'd like to link to something, but there doesn't seem to be anything to link to. If this project is killed, we darned well want to know why, because we know many patients have benefitted from this kind of therapy. (Anyone listening?) If the current incarnation is dead in the water, we will hope for a reincarnation.
Dry Eye in the News
7 August: Health tip: If your eyes are dry
Forbes. Three brief paragraphs of common sense. But we like that they mentioned cold and allergy medications as a dry eye culprit!
7 August: Ask DrH... Long use of drops safe for dry eyes?
Philadelphia Inquirer. Patient asks about long-term safety of Restasis. Answer buried in the 6 paragraphs of educational blah blah is that it 'appears safe for long-term use'.
2 August: How to relieve dry eye syndrome naturally
Emax Health: This is actually a really nice basic educational piece about dry eye causes that includes a solid list of non-drug practical steps for managing chronic dry eye. Thumbs up.
25 July: Dry eye dangers are often missed
USA Today. Humph. I wonder if the journalist was aware that dry eye is the #1 side effect of LASIK when they went and got a quote from a prominent laser surgeon. And the NWHRC gets their little plug in for Restasis... again. Pass.
25 July: Symptoms, causes, treatments for dry eye
The Arizona Republic: "Here's information to help you prevent, identify and treat the problem of dry eye...." Thoroughly respectable article.
23 July: Menopause can cause dry eye syndrome
10 News: "...Dry eye syndrome is a common condition endured by menopausal and peri-menopausal women...." Decent read.
20 July: Can-Fite Initiated Phase IIb Clinical Trials in Rheumatoid Arthritis Patients... blah blah
Genengnews.com: "the Company will shortly begin evaluating the efficacy of this drug in the treatment of dry eye syndrome..." I love the word "shortly". Fine, keep saying it, but we sure hope you actually DO it soon.
19 July: International Group Targets Sjögrens Syndrome
UCSF Today: The Sjögren's International Collaborative Clinical Alliance (SICCA) met in DC recently.... This is a group of clinical and laboratory investigators focusing on the development of the International Sjögren's Syndrome Registry. Don't know much about this organization but it's good to have one out there promoting research on prevention & treatments.
17 July: Alimera Sciences Announces Agreement with CYNACON / OCuSOFT(R), to Co-Promote OCuSOFT(R) Lid Scrub Eyelid Cleanser
PRNewsWire: Whole story in the title. This is probably a good thing as it will increase awareness of the importance of lid hygiene. Presumably prompted in part by the launch of TheraTears Sterilid product.
12 July: Sinclair Pharma: Opthalmology Product Gets Regulatory OK
Sinclair press release page: New product released in the UK as a medical device class I (sterile). From the limited information in the press release it is not clear whether this really presents some truly new or improved kind of mechanism or is basically a souped up artificial tear marketed as a prescription drug. Waiting on more info from Sinclair about active ingredients and preservatives.
1 July: New study puts the focus on dry eye
The Salt Lake Tribune: Bragging about being the seventh worst city for dry eye. Good article overall.
From the editor's desk
DRY EYES, FROM CORNER TO CORNER
I thought I was already well aware of the role of climate in dry eye, but I have to admit I gained a powerful new appreciation for it on a recent long drive I took. Long as in days, not hours. I drove from Florida to Washington state, where we had decided to move in order to be closer to our extended family.
We sprinted through northern Florida, Georgia, Tennessee, Kentucky, I think a little bit of Iowa if I remember right, southern Illinois, and Missouri - all during that awful 100+ degree heatwave so we had no motivation to do any sightseeing along the way. We finally slowed down in Nebraska, stopped to visit a friend, took a detour up a back road through the sand hills (stunningly beautiful, though we didn't get as far as we wanted due to some wildfires), took a scenic loop through the Badlands of South Dakota, and introduced my 3-year-old to Mount 'Mushmore' and the largest collection of reptiles in the world at the Reptile Gardens nearby. Running short on time, we then got back on the interstate and sped across Wyoming, Montana, the Idaho panhandle and eastern Washington.
I think it was in Tennessee that I broke my Wiley-X wraparound sunglasses. They have always been my favorites for driving - wraparound style and light foam pads give some protection from the air conditioning but with good quality vision - and I hadn't brought any spares, so I drove the rest of the trip with a $10 pair of sunglasses that didn't do a thing. That was a great test of my new sclerals - more on that shortly.
When we stopped in Nebraska, though, I could hardly stand to get out of the car. Between the heat and the wind it was awful. I just can't imagine living there with dry eye - of course not all days are that bad but outdoors activities would be a thing of the past.
On the other hand, since arriving in the Pacific Northwest, what a difference! I don't think my eyes have been this comfortable outside in an awfully long time.
MY EXPERIENCE WITH BOSTON SCLERALS: The first six weeks
As some of you already know, in late June I went to the Boston Foundation for Sight to be fitted with scleral lenses. This is a summary of my experience to date, which I am sharing both for the benefit of patients who may be interested in this kind of treatment, and for the benefit of physicians who may be interested in hearing about the efficacy and the practical details of this particular application of sclerals. If you have any questions, please don't hesitate to ask. You can always email me privately but for efficiency's sake I prefer that questions be posted in our Sclerals forum on Dry Eye Talk so that others can read the answers too.
Background
What are sclerals? Scleral lenses are basically overgrown gas permeable lenses that restore vision and protect the surface of the eye by holding a constant fluid reservoir against the eye. They were originally designed for keratoconus patients. In recent years they have increasingly been used for patients with other types of advanced corneal disease or injuries, such as Stevens Johnson Syndrome. Most recently, there have been attempts to expand their application to cases with potential for substantial but less dramatic benefits, such as patients with partially disabling photophobia, dry eye or refractive surgery complications who have not been helped with any other treatment modality.
Why did I try sclerals and what am I hoping to achieve? In a nutshell, I am just trying to achieve a sustainable solution for my vision problems. Sclerals seemed like the safest and best way to resolve my vision problems without compromising my ocular surface, and with the side benefit of actively helping my dry eyes.
Long version... I do not have any of the obvious indications for sclerals. However, I do have two problems, both dating to my LASIK surgery back in 2001:
- Poor vision: about 20/70 BCVA (meaning best vision achievable with glasses), plus multiple images, grossly reduced contrast sensitivity, and some other special effects, resulting primarily from central "islands" somehow induced by the surgery.
- Dry eyes: Not bone-dry like someone with Sjögrens - I don't have much aqueous deficiency, but I exhibit the symptoms of dry eye - pain, stinging, burning, epiphora, photophobia, and so on. I suffer in some degree or another from MGD, slight lagophthalmos, and - I suspect - a mucin layer not working very well.
For me, the vision problem has always been uppermost, but the dry eye problem has been an important hindrance to getting any solution for the vision. My vision can only be corrected with some kind of gas permeable lens, and while fitting my eyes with a gas perm is challenging enough on its own that I have had to work long-distance with a specialist for years, the dryness makes it even more of a challenge.
After two years of fitful, aborted attempts at getting an RGP resolution that would allow me to drive and work regular hours, in early 2004 I finally got into a pair of specially designed Macrolenses that gave me functional vision and that I could wear for enough hours to make them valuable. This is thanks to Greg Gemoules OD, an optometrist near Dallas who has made a specialty of therapeutic lens fitting for people with complications from refractive surgeries such as RK and LASIK. I have continued to wear these lenses pretty successfully for two and a half years.
Meantime, to keep my eye surfaces in good enough shape to tolerate the lenses and to keep them in decent comfort, I have had to use several tools, including: Dwelle, Dakrina or NutraTear eyedrops as needed; occasional saline rinses (Unisol); lid hygiene (no baby shampoo for me... just lid wipes with Unisol); heat treatment for MGD (rice bag); Panoptx wraparound eyewear for daytime supplemented by Wiley-X for driving; TranquilEyes hydrating goggle at night; and fish or flaxseed oil supplements. I have seen consistent benefits from each of these over time, enough to motivate me to continue, though my need of each individually has its ups and downs.
Fast-forward to February 2006. I had invited the Boston Foundation for Sight to send a speaker to our first annual dry eye conference in Safety Harbor, Florida. Their executive director Mark Cohen kindly joined us and spent quite a bit of time answering the myriad questions from patients during the weekend. Since then I've been getting more familiar with the work they've been doing and the types of patients they've been helping and eventually concluded it might be worth trying for myself.
While I've considered myself a successful Macrolens wearer in terms of the vision and comfort they give me while the lenses were in, I experience a lot of pain after removal and anytime not wearing them. I also worry about my tolerance for Macros long-term. It just seems like having something resting, even if only slightly, on my fragile corneas cannot be a good thing. And my needs in terms of wearing time are pretty rigorous, something I could not achieve with Macros without vision declining and comfort declining noticeably towards the end of the day. The idea of having my corneas bathed in fluid all day long was hugely attractively to me IF that could be combined with vision good enough for driving standards, e.g. 20/40.
For me, trying Sclerals was not an exercise in trying to achieve perfection - just trying to achieve functional vision on a sustainable basis, and if I could get some dry eye relief thrown in as well, that's pretty compelling for me.
The fitting process
How long did it take? Short answer, three days, but please don't expect it to be that short for you/your patients!
I have to take my hat off to Mark Cohen, Dr. Rosenthal, Dr. Johns and the rest of the team at BFS stems because I asked them to accomplish a near-impossible task in terms of timing:
Patients who travel to BFS for a fitting are required to be available for 10 days, because the time required to achieve a good fit that meets their high standards, though variable, can be considerable. I only had 3 days available. I know it was unreasonable, but my particular collection of family & business responsibilities made it impossible to spend longer. The amazing thing is that they achieved so much more than I expected or imagined in that time, and were cheerfully philosophical about the strain that must have put on resources at the time.
What was involved? Briefly, the visit revolved around a series of appointments with Dr. Rosenthal and Dr. Johns, plus training sessions with a technician on insertion, removal and care of the lenses.
We started with a very thorough history, examination, refraction, discussion, topographies, and so on. Then we moved on to the fitting process itself, which works in a cycle: Put in a trial lens, examine, try it for longer, re-examine, make a lens, try it out, examine, try it longer, re-examine, repeat all these till the best fit is achieved. This process starts in an exam room with an enormous 'library' of trial lenses. The process of selecting appropriate lenses is heavily reliant on the skills of the doctors. We start with a trial lens they think may be suitable; put them in; then test the vision and examine the fit. When we get something that looks promising (that does not take long), I hang out somewhere else in the clinic for awhile so that they can look at how the lenses look after wearing them for awhile. It's been a while now and I'm a bit hazy on the details of how quickly we went to production on a new lens after wearing a trial.
When we've got a winner, we have a lens made. Each lens at BFS is individually lathed for the patient to the specifications determined by the doctor. In my case, because of my dry eyes, the lenses also had to be plasma-treated. Given that we went from 0 to 100 in just three days, and made - I don't remember now but I think at least 3 lenses for each eyes, you can imagine how rapidly this process moved along and how much was done.
Somewhere during lens iterations, there was an interesting minor equipment failure that I found educational.... A lens that was supposed to be plasma-treated did not appear to be treated. This was immediately apparent on inserting the lens, because it didn't "wet" properly. Most of the other lenses I'd tried had excellent wetting but this one seemed to fog over immediately. I had not realized before what a difference something like that could make. When the same lens was finally treated, it performed fine.
I had to cut the whole thing short prematurely because of time constraints. When I left the Foundation on Wednesday, I was supposed to come back in the morning. I tried to get my flight changed to allow me to do so, however, it was on a bad travel day and due to flight cancellations everything was booked up solid with long standby lists, so I did not make it back in. My last pair of lenses, I just kind of took it on faith that they would work out. Thank God they did.
And the training process? This part was almost certainly different for me than it would have been for the vast majority of patients because of my background. Having worn Macrolenses for years, putting a big gas perm in my eye and using a "plunger" to remove it was no big deal, and with the exception of hydrogen peroxide to soak the lenses, I was already using the same lens care products. The only really new thing to me was the special device used to insert the lenses, and I had to practice the insertion technique a bit as the lenses really are quite a bit bigger than Macros. I would expect though, from what I heard and observed, that most patients would spend a lot more time in training than I did, thoroughly familiarizing themselves with everything and getting more comfortable with the process. The technician was excellent, very patient and detail-oriented.
What's the place like? The Foundation is a fascinating place to me. It's got all the warmth and caring of a family, and patients are really pampered and cared for. But the collective brainpower and experience within those walls is awesome, from the lab where the lenses are made on six-figure equipment right up to the doctors fitting the lenses. It's all state-of-the-art. What I most appreciated about it though is the doctor time lavished on patients. One of the complaints I hear most frequently on Dry Eye Talk from patients is, "I waited all that time/flew to XXX city/etc etc and the doctor just rushed me through in about 5 minutes". There are plenty of exceptions to that - hidden gems here and there, doctors that can manage to put patients needs over profits and paperwork. It's really inspiring to see an entire medical facility run on the principle of doing the best job possible for the patient.
Adaptation period
I would expect that in some ways the adjustment must have been simpler and shorter for me than for a lot of other patients, because of my background. If you'd never worn contact lenses at all, or had only worn standard-size RGPs or soft lenses, the strangeness factor could conceivably be considerable. Just the insertion and removal process would be so new that it would take a little while to get used to it. And there's the visuals. I work around eyeballs, and pictures or videos of gory-looking eye diseases don't faze me, but I can imagine that for "normal" people, seeing your eyeball squeezed into a slightly different shape (temorarily) after removing a lens might be unnerving, even if you know it's harmless. It only happened to me a couple of times, but I remember saying to myself, "If I were the type to get grossed out easily, I'd be feeling kind of funny right now." - The only problem I did run into was with some initial dizziness & headaches. As far as I've been able to find out, that's not happened to anyone else, so I haven't really pinned down why it happened to me, and after a few days it subsided, but initially it slowed me down.
I can't really think of any other aspect that might be a struggle for a new user, but I wouldn't be surprised to hear there are some, especially from those who have never before worn contact lenses. Different perspectives, different experiences. The staff at BFS do so much though to prepare you that I think if patients spend the proper amount of time there (I didn't) they'd get past most of that before even returning home.
Results
Vision (daytime): In the context of my vision history, the results are outstanding. Truthfully, assuming 6 weeks to be a decent trial period, I have not seen this well this consistently in five years. My dominant right eye which has always been very troublesome now gives me terrific vision - probably 20/25 or 20/30, and very clean, unaberrated - and, most importantly, it stays stable pretty much all day. If that doesn't sound impressive enough, it should, because getting my vision to a 'clean' 20/30 has always proven a difficult task on my very flat, irregular, highly aberrated corneas. My left eye is probably a little bit behind the right in terms of acuity but it's my non-dominant eye and I've found that having my right eye perform so well makes a very noticeable difference, especially while driving. I'd kind of adapted myself to having to do a lot of u-turns because I can't read signs in time, but I'm finding now I am doing a lot better with signs.
Vision (nighttime): I know plenty of LASIK patients out there are going to be curious about what the sclerals do for my night vision. For reference my spherical aberrations are way off the chart. (I was about -12.00 prior to LASIK and had smaller than a 6mm programmed optical zone on a 7.5mm dark-adapted pupil.) With my Macros, since DrG was far away I'd simply never been able to invest the time to give him an opportunity to optimize the lenses for night vision. My main goal was and is just functional daytime vision, so once I've got something that works I just cut & run. The Macros improved my contrast greatly but did not relieve starbursting, haloes etc. much. Now, with sclerals, to be honest I am so much out of the habit of venturing out at night that I don't have a lot to report yet. I will report back more when I've put more effort into it. (And like with my Macros, this wasn't my goal - and again there was no time to focus on it.)
So far, I have noticed small starbursts while driving at dusk; more so in my left eye than my right. Overall from what little I've observed I think that what I can safely say is this: There appears to be a large enough reduction in overall aberrations for me that I would have no difficulty believing this MAY be a very effective way of improving night vision symptoms in patients for whom that is a primary complaint. I would be very interested to see the results of trying that out on several patients who like me had a large pupil/treatment zone gap on a moderate to high prescription. The literature has proven that higher order aberrations can be dramatically reduced with a corneal or corneal-scleral lens so logically, it stands to reason that it can be done with a scleral lens.
Comfort while wearing lenses: Excellent. I pretty much don't notice them most of the day. In the evening I start to notice them. They're never painful or bothersome, I just start having some kind of 'sensations' in the evening, enough that I'm quite ready to take them out by bedtime. I believe that if I were to remove them at least once during the day, I could get increased comfort during the evening, however, so far I just plain haven't been motivated.
What has really surprised me about the lenses is how little I need to lubricate them. I started out lubricating them with NutraTear every 3 hours or so, but it really turned out to be unnecessary. I can sometimes go as long as 12 hours without a drop of anything.
Wear time: I put them in when I wake up and I take them out just before bed. Hard to beat that.
I have to believe that "your mileage may vary", especially for those who have severe aqueous deficiency. Lens-lid lubrication has to present some real challenges for very dry patients. I think that my mileage with these lenses is far greater than I was told to expect, so I've been vastly pleased from that standpoint.
Dry eye symptoms: Now that's the wonderful part! When I take them out at night MY EYES DON'T HURT! What a concept. I can be placid about all the other aspects (or almost... I do really like being able to read my exit sign before I drive past the exit) but this one still has me amazed, every single night. I can get into bed at night and not be in pain! WOO HOOOOOOOOO! I can take lenses out and not immediately slap a washcloth over my eyes or squirt saline at them to try and stave off the pain! Yee haw.
Seriously, it's really something. I think that it is still early to draw any conclusions about long-term benefits, but in the short term, I can definitely point to improved overall nighttime comfort. I have even cut down on using drops and TranquilEyes at night. An interesting thing I discovered in this process was how much of the pain I had simply adapted to and tuned out. I noticed the pain more from its absence than its presence. I was thinking about that and how incredible it was to have my eyes feel so good at the end of the day and it suddenly struck me that I never really thought of my eyes as being THAT "bad" at the end of the day till... I experienced what "good" can feel like.
Another big test of what Sclerals can do (for me) was during my recent move. I drove across the country during a heat wave and was able to do 500 or more miles every day. I honestly don't think I could have done that without the sclerals. I had my 3-year-old with me, so just sweating it out wasn't an option, and I think my eyes would have been hamburger (and my vision crud) from the air conditioning.
My routine now
Lens care (in the eye): I use NutraTear to lubricate my lenses when needed during the day. NutraTear was instrumental to my success in Macrolenses and, though to a lesser extent, I think it's also important with my sclerals - feels great and keeps things going longer. (It's also the only drop I've ever been able to tolerate the feel of over a contact.) Occasionally, in the evening, I might douse them with Unisol for the feelgood factor to keep me going a little longer.
Lens care (out of the eye): I soak them in hydrogen peroxide. I clean them with Lobob Extra Strength Cleaner (wonderful stuff, always used it with my Macros as well). I rinse and insert them with Unisol. I don't know how anybody with long nails could possibly clean a lens like this - you'd probably have to have one nail short for the purpose.
Insertion/removal: Nothing special to say. I pretty much get them in fine on the first try. Removing them, the first few days I struggled a little and got a little worried. That stuck feeling... that "thwaaack" sound, ugh! But, I was trading experienced with a kind and much more experienced friend shared some tips (thanks Phillipp!!) and I found that a little bit of clockwise rotation made all the difference in the world and now they always come out immediately with no difficulty at all. Oh - and I always put a towel in the sink first. The lenses often drop into the sink while removing them and I wouldn't want to risk breaking or losing one.
Dry eye care: Right now I'm in the Pacific Northwest and so it's hard to gauge what's climate-related and what's lens-related but I'm going through a stretch where I seem to need blessedly little to keep me going. I'm not even using drops at night. Presumably the absence of air conditioning is making a fair amount of the difference. However, I was already experiencing some progressive improvement while in Florida. There, I still definitely needed wraparound eyewear outdoors (I don't seem to here as much). Sclerals by day and TranquilEyes by night seemed to make a huge difference to overnight dryness there; here I haven't bothered with the TranquilEyes - though I suspect I will need to as soon as we start having to turn the heat on. For now, I'm just enjoying the break!
Conclusions?
My first six weeks in sclerals has been thoroughly successful in terms of visual performance, lens comfort, wear time and dry eye symptoms. I do not find any aspect of lens care unduly burdensome. I'm 100% pleased with the results.
This has encouraged me to hope that it may be a good solution for some other patients like me who don't appear to fit the "classic" profile of a scleral candidate (keratoconus, Stevens Johnson Syndrome, etc) but yet who have corneal disease or injury conditions that have not been satisfactorily addressed through other means. It has also thoroughly convinced me that the people who DO fit the "classic" profile ought to consider this as their #1 treatment of choice - especially if the alternatives are surgery.
A note for the LASIK patients reading this
I would like to share a few thoughts for a group I always have close to my heart, LASIK complications patients, some of whom may be considering sclerals. (Some of this also applies to patients with severe chronic dry eye symptoms from other causes such as drug side effects.)
While my problems are exclusively LASIK related, I am not necessarily a good benchmark for post-LASIK use of sclerals. I had an uncommonly large loss of BCVA, so in one respect at least, I have a lot more to gain from lenses in terms of basic functionality than most patients, meaning that one could fairly expect I'd be more tolerant of drawbacks or perceived "hassle factors" or cost than other patients. Looking at the more typical LASIK patient such as the ones I've met on SurgicalEyes and D'Eyealogues and Dry Eye Talk over the years, the issues are usually night vision symptoms and severe dry eye symptoms. My experience has certainly made me most hopeful that such patients could find their symptoms greatly alleviated with sclerals.
However, the question of acceptable benefits and acceptable tradeoffs is intensely individual. Without meaning this in the least as a slight, I believe that taken in the mass, LASIK patients have higher expectations from treatments and lower tolerance of tradeoffs than people suffering from eye diseases they came by gradually.
I think that LASIK patients seeking help from sclerals, particularly for severe dry eye or for dry eye plus night vision problems, still have much to gain. But I think that in order to maximize their chances for success, they ought to take a number of preparatory steps before actively pursuing sclerals, including: a) learning as much as possible about the entire process (including the fitting process, lens care and so on), and b) identifying very specific goals for themselves. You can't go into something like this with the expectation of a magic bullet that will reverse the past. You have to say to yourself, "What is it I really want most? What activity would I like to be able to do again, that would make this all worthwhile? or, What are the top three things I have missed most since my surgery?" I think that putting a very well defined face on your expectations is a good recipe for success.
Acknowledgments
I owe an enormous debt of gratitude - to Mark Cohen for painstakingly educating me about BFS and sclerals and for so kindly facilitating my visit there; to Drs. Rosenthal and Johns for working so hard to get my fitting done under excessive time constraits and for doing such a brilliant job of it; and to the entire staff at BFS for their kindness and excellent work. What a terrific team. - Dr. Rosenthal has done an incredible service to the world by developing this treatment and making it available through a nonprofit foundation. Well done.
Pardon the typos... I was so late getting this done I haven't proofread yet.
Have a great month everyone.
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