Sunday, August 20, 2006

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.