Definitions & Notes (applicable throughout this document,
unless otherwise noted):
The term Lasik may be used to refer to both Lasik and PRK. Issues involving flaps do not apply to the later.
The term warranty refers to the period of time (varies with each physician, often around 12-18 months) after the ICL™ surgery, during which most (but not all) follow-up care is covered by the fee that was paid before the surgery. Usually includes checkup visits, treatment of infection & other minor complications, and the fine-tuning of visual acuity with lens-swapping and/or Lasik. In this context, the term warranty generally DOES NOT imply any level of guaranteed satisfaction, merely what services are covered by pre-paid monies within a finite window of time after the initial procedure. Major complications (retinal detachment, cataracts, etc.,) are also probably not covered by the ICL™ physicians’ warranty (but are likely to be covered by your general medical insurance). Review the details with your doctor(s) thoroughly!
Terms highlighted in blue (without an underline) are not hyperlinks meant to lead you to other information. They are merely accents to help identify the subject of a passage.
1. Some ICL™ patients report a phenomena called PILIs -- Peripheral Iridotomy Leak Images, distortions/artifacts caused by the PI holes -- as described in the quotes below taken from http://health.groups.yahoo.com/group/piolusers/ ):
"... two faint images that are sometimes present due to the PI holes."
"Sometimes they also appear as a lot of tiny, sunny pinprick holes at the bottom of my vision."
"It's like you are looking through hairs in your line of sight."
".... I also experience this glare as horizontal smudgy lines low in my field of vision"
"My surgeon used YAG laser and next morning straight away I noticed all the symptoms; faint / smudgy clear horizontal lines every time I blink, ghost image of every light source during day & night, glare when the eyelid opens wide etc."
"The glare is just like looking through several pieces of hair or a dewy spiderweb"
“I'm still really bothered by the lines I see when I blink due to the iridotomy holes :(“
As a patient, I want the best chance of minimizing PILIs. As a surgeon, you want to optimize intra-ocular pressure by having the best flow of fluid between anterior & posterior chambers.
(a) How many PI holes (or slits) do you create in each eye?
(b) Do you create them mechanically or with a YAG Laser? What are the advantages/disadvantages of each method? Is there any evidence that the degree-to-which-PILIs-annoy-the-patient is correlated to the method of PI creation?
(c) How close to the sclera can you place my PI holes/slits (to get them as far under my eyelid as possible)? Do you know everything you need to know about my eyes (especially the Iris) to be firm in that decision now, or will you need to do further exams? I’m reluctant to commit to this surgery until I know that my risk of PILIs won’t change on the day of the PI because the surgeon wavered at the last minute about the hole/slit locations. Please show me where you will drill my PI holes:
(d) Is there any software that can simulate what my PILIs might be like?
http://www.surgicaleyes.org/visual_effects/visual_effects.swf
(e) Suppose my eyelids don’t cover the PI holes very well. Is there ….
· …. any medication and/or surgery that can lower the eyelid to improve the coverage of the PI holes (without crossing over too much into the pupil)? Would this even help much if dispersion inside the anterior chamber of the eye is a significant source of PILIs?
· …. any research being done to develop some kind of localized dye application to block incoming light to the PI holes? Something like a bio-friendly ink that can be injected just below the surface of the cornea right above the holes. Or is the efficacy of a localized blocker ‘tattoo’ again going to be imperfect due to the dispersion/scattering of light inside the anterior chamber?
(f) Can the PILIs that we notice after the PI -- but before the ICL™ surgery -- get better or worse after the ICL™ surgery, due to the vaulting angle moving the Iris and changing the effective aperture of the PI hole?
(g) Is there any evidence that the degree-of-annoyance-to-the-patient of PILIs is correlated to Iris color? i.e., would patients with lighter Irises (green, light blue) be likely to be bothered ___more or ___less than those with darker Irises (brown, dark blue)?
2. Some previous patients report evidence of post-ICL™ Halos (even long after the surgery). Can you provide the following information ….
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Left Eye |
Right Eye |
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What’s my maximum pupil diameter under normal room-lighting conditions? |
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Millimeters |
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What’s my maximum pupil diameter under dark conditions (measured using Infrared Pupilometry?) that approximate the visual environment of night driving with point sources of light? |
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Millimeters |
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To what degree, if any, are my pupils off-center with respect to the natural lens? |
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Millimeters
@ “___ o’clock” |
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What’s the optic diameter of the ICL™ lens that you propose to install in my eyes? ….. I’m NOT looking for the range of the manufacturers’ entire ICL™ product line (reportedly 4.9-5.8 mm), but the specific diameter of the lenses I would get. |
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|
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Millimeters |
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What’s the edge diameter of the ICL™ lens that you propose to install in my eyes? |
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Millimeters |
…. and comment on the probabilities that -- and circumstances under which -- I might experience problems with halos (or starburst, glare, etc.,), especially during outdoor nighttime activities (i.e., driving), when the pupils are largest?
(a) What is the algorithm for determining the probability of experiencing halos?
· Is it merely a binary decision about whether the pupil diameter is greater than the ICL™ optic diameter? (I ___do ___ don’t get nighttime halos when wearing my coke-bottle-thick glasses that fail to cover my whole field of vision)
· Does it have anything to do with the grading/tapering (or lack thereof) at the boundary between the optic & non-optic portions of the ICL™?
· Are there other mechanisms that cause/contribute to halos?
(b) Is the ICL™ lens optic diameter a function of the degree of myopia to be corrected? All other things being equal, is the patient with the greater degree of myopia (i.e., -15D uncorrected) going to get a smaller optic diameter ICL™ than someone with milder myopia (i.e., -6D uncorrected)?
(c) If my pupils are off-center, is the ICL™ lined up with the pupil or the natural lens? Would awaiting Toric lenses be the best approach to mitigating this contributor to Halos (or other visual aberrations)?
(d) Do the sizes (in day or night) of my pupils change as a function of age? i.e., If I get post- ICL™ Halos now, should I expect them to improve or worsen as I get older?
(e) Does Iris color have a role to play in the likelihood of -- or degree of annoyance in -- seeing halos?
(f) Can you test for a patients’ ability to tolerate unfocused peripheral light? i.e., using diagnostic tools such as
· variable-diameter lenses in the Phoropter
· smaller-than-normal-diameter contact lenses
(g) Is there any software that can simulate what my halos might be like?
http://www.surgicaleyes.org/visual_effects/visual_effects.swf
(h) Is/Can the non-optic portion of the ICL™ (specifically the periphery around the lens optic = the material in between the optic diameter & the edge diameter) be made opaque? i.e., dyed with a darker-colored Collamer, to prevent light from getting through places we don’t want it to get through.
(i) If the vaulting ends up being on the high side, can my night-time pupil size change after the ICL™ is installed? If so, would that be likely to improve (smaller) or worsen (larger) the incidence of halos?
(j) If my halos turn out to be non-trivial and bothersome, what medication(s) would you be recommending for me to use as a pupil constrictor? And …..
ü What kind of annual budget should I reserve for this medication?
ü Is it available over-the-counter or only by prescription?
ü What other medical conditions would contraindicate its use?
ü Is pupil constriction the prime intent of this medication or merely a side effect?
ü Will pupil constriction with this medication be reliable or inconsistent?
ü Can ICL™ patients experiencing halos take this, say once per day (before possible night driving/activities) for ___ days per week for ____ years, without ….
§ …. long-term health risks to the eyes? (i.e., will my Iris' tissues / ocular blood vessels mind this chemically-induced expansion/contraction in perpetuity?)
§ …. fear of side-effects including (but not limited to)
Ø dry-eye
Ø glaucoma
Ø blurred vision
Ø upper lid retraction (permitting an increase in PILIs)
Ø fatigue / dizziness / decrease in mental alertness (i.e., a huge contraindication for trying to mitigate halos at night, when we’re often driving)
Ø further risk of retinal detachment (above & beyond what the surgery exposed me to)
§ …. discomfort or pain at the time they’re applied?
§ …. discomfort or pain for the duration over which they’re effective?
§ …. the drug losing its long-term effectiveness? If this occurs, what do we do to mitigate halos once the body has adapted to the drugs and their efficacy is inadequate? If we can’t do anything about this with medication or further surgery, can contact lenses or glasses fix halos?
§ …. fear of being discontinued? In the 1990’s, there was an anti-dilation eyedrop, called Rev-Eyes, that has since been terminated due to patent issues or raw material unavailability (depending on who you ask). The retirement of Rev-Eyes was a mere inconvenience due to its use once per year at an eye exam. The similar retirement of an anti-halo medicine could be disastrous for the safety of an ICL™ patient who does a lot of night driving.
ü Before committing to ICLs™, can you test these medications on me for ….
§ …. their pupil-constricting efficacy (assuming you have Infrared Pupilometry instruments)?
§ …. the critical side-effect of fatigue / dizziness / decrease in mental alertness? Would side-effects testing be done better with a limited prescription that I can try over the course of a week or two (instead of just once in your office)?
3. The following uninspiring passage was written in 2003 ….
Power calculations for phakic IOLs are done by the manufacturer. “We don’t have a good sizing method yet, ”Dr. Salz added. “We tell the manufacturer, here is a –12 D patient. This is their anterior chamber depth, and this is the white-to-white measurement with calipers, and they send you the lens. As ultrasound studies become more sophisticated, we will probably get a better way to size.”
-- http://www.visianinfo.com/pdf/implantable_contacts_make_mark.pdf
(a) What’s the current state-of-the-art in methodologies & instruments for ICL™ selection/sizing/customizing/fitting? Which, if any, of the following are you currently using, and how much experience (# of ICL™ patients sized with it) do you have?
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Manufacturer |
Instrument |
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ArcScan |
Artemis
2 |
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Zeiss |
IOLMaster |
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Quantel
Medical |
Lin50 |
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Zeiss |
Visante
OCT |
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Sonomed |
VuMax |
(b) How many different sizes (haptic-to-haptic lengths) are available in the current generation of ICLs™? Given that, how much resolution of the measuring system is good enough? How does your instrument-of-choice compare to the resolution & accuracy of the white-to-white measurement?
4. ICLs™
received USFDA approval relatively recently (December 2005). In what year(s)
did ICLs™ get approved in other nations and (roughly) how many patients are
there worldwide? How much long-term, real-world history do we have with
this technology? When you speak of risks & results, will you be basing that
on your knowledge of
·
the eyes that were part of the USFDA clinical
trials
·
the eyes that you’ve personally operated on
· the longer-term data from outside the USA
5. The Lasik industry boasts about their capacity to do Wavefront measurements to correct high-order imperfections (the ‘fingerprint’ of your eyes) that glasses and regular contact lenses cannot. Does Wavefront have any role to play in customizing ICL™ lenses to optimize the individual’s vision? If so, does the PreVue® lens have a role to play in showing prospective patients what post-ICL™ vision looks like?
6. Suppose I’m astigmatic. Are there any contraindications for getting regular ICLs™ now (supplemented with lighter-weight glasses to handle the astigmatism) and upgrading to Toric ICLs™ later (and throwing those glasses away) when they get USFDA approval?
7. Will having ICLs™ prevent me from undergoing any of the currently-practiced surgical treatments for Presbyopia? To what extent, if any, might these degrade my ICL™-corrected distance vision?
8. The manufacturer’s literature claims that “Over 99.4% of patients …. were satisfied with their vision after the Visian ICL™ procedure.”
(a) What was the definition of satisfaction?
ü Unconditional delight
ü Positives (i.e., terrific daylight vision) outweigh the negatives (i.e., PILIs & nighttime halos)
ü None (self-defined by each patient)
ü Other ____________________
(b) What were the most common reasons for dissatisfaction among the remaining 0.6%? What, if anything, was done to mitigate that dissatisfaction?
(c) Are
the details of that survey available to the public? If so, what’s the name
and/or web address of the independent agency (i.e., Consumers Union®)
that conducted it?
9. I’ve
read that ICLs™ are now up to version ___. Can you comment on
the history of these versions, what’s been improved, and why I don’t need to
wait for the
next version?
10. In the Lasik world, some physicians & Laser manufacturers advertise their ability to do Iris Registration to compensate for cyclotorsional movement and/or pupil migration that occurs as the patient moves between upright and supine positions. How does ICL™ technology deal with this phenomenon?
11. We’ve heard that the USFDA issued some kind of warning against the manufacturer in connection with ICLs™, yet I can’t find anything about this issue on their website. In layman’s terms:
(a) What was the nature of the charge(s)?
(b) What was the manufacturer’s response / corrective actions?
(c) Why should this warning not lower our confidence in this technology and/or our trust in this company?
12. The manufacturer’s
literature claims that the ICL™ does not touch any internal eye structures.
(a)
If true, what’s the purpose of the 4 tabs we
see at the periphery of the ICL™ lens in photos throughout the promotional
material?
(b) If true,
what’s keeping the ICL™ from drifting around inside the posterior
chamber? In the absence of “not touching any internal eye structures”, won’t we
get
·
variable vision as the focal point dithers
around the z-axis with respect to where it should be focused on the retina?
·
cataracts caused by the ICL™ bumping into the
natural lens?
(c) This
contradicts some information in the literature that suggests that some range(s)
of proper vaulting may include the case where the anterior surface of the ICL™ is
rubbing up against the posterior surface of the Iris.
13. The
manufacturer’s literature says that the ICL™ provides an ideal platform for future toric
correction ….with no further explanation. This seems odd, given that
most prospective patients won’t know the definition of the word toric
(= astigmatism i.e., an asymmetric
cornea). Would it be correct to say that, in layman’s terms, this phrase means our ICL™ will take care of all (most) of
your myopia, leaving a little Lasik work to tweak your astigmatism (and any
residual myopia)?
14. The
manufacturer’s literature suggests that the age range for ICL™ surgery is
18-45. The 18 part I understand. Why are people over 45 prohibited /
discouraged from pursuing ICL™ vision correction? Isn’t that merely an off-label use of the technology?
15. What
are the risks that the ICL™ procedure itself causes further degradation?
i.e., Can the eye distort as a reaction
to the trauma of the ICL™ surgery? Would such a change be more likely to be
a shift in myopia
or astigmatism?
16. Does the ICL™ lens design (and selection by the refractive surgeon) account for the change in temperature it will experience when placed inside the eye? Even though our bodies try to regulate internal temperature, since the eye is so close to the outside environment, how much can our ICL™-corrected visual acuity change by going into environments of extreme heat, cold, or humidity (deserts, polar regions, tropical jungles)?
17. Can ICL™ surgery increase the number of ‘floaters’ in the eye caused by
(a) dislodging already-loose material on the retina into the vitreous humor (due to the unavoidable tugging on the eyeball during surgery)
(b) dust motes in the air entering the anterior chamber during the surgery?
Can the surgeon 'vacuum out' type (b) floaters at the end of the ICL™ surgery?
18. Are Halos, PILIs, glare, starburst, or any other ICL™-induced visual distortions (not including imperfect distance focusing) manifested in far-away-vision only? Can any of them occur close-up when reading (indoors with good lighting) and/or working on the computer?
19. Does post-ICL™ Lasik have any role to play in minimizing Halos, PILIs, glare, starburst, or any other ICL™-induced visual distortions (aside from imperfect distance focusing, which we already know is Lasik’s prime post-ICL™ application)?
20. Suppose either of the following scenarios should occur ….
(a) The ICL™ X-Y position becomes de-centered (and we’re not happy with the resulting visual distortions/artifacts).
(b) The ICL™ migrates on the Z-axis to a point where it looks like the vaulting is relatively flat and close to the crystalline lens (and we want to mitigate the possibility of inducing cataracts from poor aqueous flow around the lens).
Can you do secondary position-adjustment surgeries to move the lens around (in 3 dimensions for case (b))? If yes, what % of your ICL™ patients undergo such tune-up procedures? How do the risks of such surgeries compare to the risks of primary ICL™ implantation? Would the scar/seal of the flap from a Lasik enhancement surgery prevent you from making safe port incisions for ICL™ adjustment? What would be the cost, if this occurs beyond the warranty period?
21. Suppose after the ICL™ settling time (when the THIS IS IT vision has been achieved), the ICL™ is structurally secure, the eye is healthy, but the patient is not satisfied with the effective corrected quality of vision due to the prescription/positioning being non-optimal. Under what circumstances are you willing to do post-ICL™ refinement by (a) swapping one or both ICLs™ with a better-prescription ICL™ vs. (b) performing Lasik? How open are you to swapping out lenses if we’re beyond the warranty period and I’m willing to pay the full fee?
22. Let’s assume that -- within the context of my eyes & surgical outcome -- you insist upon Lasik tweaking as the method to fine-tune my vision ….
(a) Which Lasik make & model do you use?
(b) Is it truly Wavefront-capable? Does Wavefront even matter in post-ICL™ refinement?
(c) Does it do Iris Registration?
(d) Does it compensate for the “cosine-offset” effect? i.e., calibrated for the fact that the beam at the cornea periphery -- unlike the beam at the cornea center -- is elliptical, and thus scatters & reflects energy.
(e) Does it track the eye in 3 dimensions? i.e., Z- as well as X- and Y-
(f) Is Lasik tweaking equally applicable for over-correction as well as under-correction?
(g) Given the thickness of my corneas (____ microns L, ____ microns R), and the ±____ diopter range of inaccuracy that you’re currently experiencing with ICLs™, would Lasik tweaking leave me with a safe margin of remaining cornea thickness?
(h) Are we limited in choosing from among the following techniques (to prevent pressure on the post- ICL™ eye from disturbing the positioning, and thus the baseline correction, that the Lasik/PRK is trying to improve upon)?
ü PRK
ü Lasik w/ keratome flap creation
ü Lasik w/ Intralase flap creation
(i) When I eventually have the ICL™ removed for cataract surgery, will the Lasik tweak on my cornea adversely affect the selection/sizing/customizing/fitting of the man-made cataract lens replacement?
23. The manufacturer’s literature says that the best ICL™ candidates are people without a history of ophthalmic diseases such as glaucoma, iritis, or diabetic retinopathy. What happens if I don't have any of these conditions pre-ICL™, but they develop afterwards? Do I have to get the ICLs™ surgically extracted?
24. ICL™ surgery seems to carry some grave risks, namely cataracts, retinal detachment, and cornea replacement due to endothelial cell loss. To your knowledge, is there any history (not just your practice, but throughout the industry) of insurance companies refusing the claim that they ought to pay for the treatment of those problems because the patient induced them via man-made, elective surgery instead of “nature”?
25. If I get Retinal Detachment from the ICL™ surgery, will the ICLs™ have to be removed to fix the RD, or can they remain? If they have to be removed, can they be re-installed after the RD fix (assuming I’m willing to take the risk of more RD)?
26. Suppose the ICL™ induces a cataract in one eye, necessitating an RLE/CLE procedure that removes the ICL™ plus the natural lens to be replaced by an artificial lens (aphakic IOL). Suppose further that the patient is presbyopic (relies on reading glasses). Since there are several kinds of modern AIOLs that can do accommodation, would you also do RLE/CLE on the other eye (that didn’t have the ICL™-induced cataract) so the patient can dispense with the absurdity of reading glasses for just one eye?
27. If the ICL™ has to be taken out ….
(a) Is it extracted whole, or first broken up into pieces and the pieces then sucked out? i.e., any risk of debris remaining in the eye?
(b) The incision for inserting ICLs™ is reportedly ≤ 3 mm. How big is the incision for extracting them? Is that also suture-less?
(c) Can the PI holes be closed (sutured / filled-in) surgically?
(d) Are the probabilities & consequences of damaging tissue (Iris, Cornea, Natural Lens, etc.,) greater or lesser than when the ICL™ was inserted?
28. Aside from the immediate post-surgery avoidance of such activities, are there any long-term limitations/restrictions on
(a) aerobic exercise?
(b) weight-training?
(c) swimming? i.e., Can we swim and open our eyes underwater without goggles/mask, to the same depths, in the same types of water (salt vs. chlorinated), as we could before the surgery, but without damaging our eyes or the ICLs™?
29. Individuals participating in contact sports (Football, Hockey, Martial Arts, Lacrosse, Rugby, and Boxing) always have the burden of responsibility in protecting themselves from direct trauma to the cornea that occurs if fists, baseballs, hockey pucks, etc., strike in/around an unprotected orbital socket.
However -- assuming that the orbital socket & cornea are completely protected -- what are the risks of indirect trauma occurring to the Natural Crystalline Lens or Iris due to flexion (deform reversibly under stress) of the ICL™ as momentum is transferred to the head by events like the following?
· an errant pitch (puck) to the head in baseball (hockey)
· a tackle (body check) in football (hockey)
Mechanical engineers call it Sway Space when object A (the ICL™) is encapsulated within cavity B (the posterior chamber & the Iris and Natural Lens abutting it), and some energy impinging from outside initiates two distinct (and often out-of-phase) damped oscillations during which A & B can collide, before they both return to some rest position.
(a) What effect could such an event have on ….
I. …. the post-impact positioning of an ICL™ within the posterior chamber, and thus the maintenance of the desired visual acuity? (i.e., can a contact sport collision turn ICL™-enhanced 20/20 vision into 20/__ vision?)
II. …. damage to the tissues surrounding the ICL™ that could require further surgery (including, but not limited to, cataracts or removal of the ICLs™)?
(b) Has any testing and/or analysis been done to support a position on (a)? Was any such testing and/or analysis part of the USFDA approval process?
(c) Has the ICL™ manufacturer polled any of the official NFL or NHL team ophthalmologists -- or the medical committees of any of the governing bodies for various contact sports -- to solicit their opinion about the efficacy & safety of this product as it relates to their sport?
(d) Has the ICL™ manufacturer polled any of the U.S. Armed Forces (Navy, Air Force, Marines, and Army) to solicit their opinion about the efficacy & safety of this product as it relates to the high G-forces that an ICL™-equipped aviator would experience?
30. For a given age range, how likely are we to experience a change in myopia? i.e., if we get surgical treatment now, what are the odds of having to get more correction in the future?
(a) Where can we find the histogram showing what percent of all myopes experience a change (doesn’t matter if it gets worse or better) in their distance vision (not including presbyopia) as a function of age? See example chart below.
(b) Should there be multiple graphs? i.e., does this chart look significantly different if we isolated the sample population as a function of race or gender?
31. Endothelial cell loss seems to be a peculiar, and little-understood, risk
of ICL™ usage.
Note to the prospective patient: this where the
doctor’s knowledge of the (longer-term)
worldwide database is important. See question #4.
(a)
What are the latest statistics at which
patients have developed serious complications from endothelial cell loss?
·
What percent of those were managed by simply
removing the ICL™?
·
What percent of those needed a cornea
transplant or other surgical intervention?
·
What are the risks & success rates of
cornea transplantation?
(b) Besides
cornea transplantation & ICL™ extraction, are there any other treatments
that can manage the endothelial cell loss problem? What is the
state of research to treat or prevent this in the near-future w/o removing the ICL™?
(c) How
often do my endo counts need to be made to reasonably assure successful
intervention (removal of the ICL™) before I would even need to worry about
corneal transplantation?
(d)
What
does the typical
endothelial cell loss profile look like? Does it
· follow a linear ___%/year curve for as long as the ICL™ is present? (see red line)
· saturate/peak out at ___% (total) after ___ years? (see blue line)
· follow some other pattern/trend?
(e) Is there
any pre-op
measurement or characteristic that is statistically predictive that
such problems will (more likely vs. less likely) occur for a given patient?
(f) Do we
know why endothelial cell loss occurs for ____ years after ICL™ surgery?
·
The trauma of the surgery?
·
Something bio-/electro-chemical about the ICLs™ ‘leaches’
the endothelial cells sitting ___ mm away?
· Could the PI holes failure to provide as much fluid exchange between anterior and posterior chambers (as the unobstructed pre-ICL™ pupil did) contribute?
32. Besides being an Ophthalmologist, what other training makes you a superior surgeon for ICLs™?
(a) Are you board-certified by the American Board of Ophthalmology?
(b) Are you fellowship-trained in cornea or refractive surgery?
(c) If your name is included on the physician-finder page of the manufacturers’ website, what did you have to do to be included on that list?
(d) Have you ever participated -- or been a principal investigator -- in a clinical trial for (a) ICLs™ or (b) any other refractive surgical procedure/technology?
(e) How many eyeballs have you cracked open for Cataract/RLE procedures? (supposedly the best training for ICL™ surgery besides ICL™ surgery)
(f) How many eyeballs have you cracked open for ICL™ insertion? How many were on ICL™ patients who had pre-op scripts within +/- ___ diopters of mine?
(g) How many eyeballs have you cracked open for ICL™ extraction? What % of those had their ICLs™ removed at the patients’ request? What % were removed by necessity (medical complication)?
33. Given what you know of previous ICL™ patients that had pre-op scripts within +/- ___ diopters of mine, can you estimate the probability that I will get 20/20 or better (a) just with ICL™ surgery, and (b) including any enhancement/ touch-up surgery? Is this opinion based on your previous ICL™ patients or the USFDA clinical studies or the world-wide database?
34. How many previous ICL™ patients of yours can your office staff get me in touch with?
35. Do your ICL™ surgical results get summarized, studied, and published in any peer-reviewed medical journals? If so, which issues of which journals? Was this for the regular 2005-USFDA-approved ICLs™, or for clinical trials of new, as-yet-unapproved IOLs?
36. Besides real patients, what do you practice ICL™ surgery on? How often do you practice? What is a Lens Loading Wet Lab?
37. Let’s talk about USAEYES’ CRSQA (or their affiliated programs: International Society for Refractive Surgery's GLORY program, American Board of Eye Surgery) http://www.usaeyes.org/lasik/faq/best-lasik-doctor.htm ....
(a) Are you certified by them?
(b) Does USAEYES’ CRSQA certification hold much value in screening physicians for ICL™ surgery? Or are they too Lasik-oriented?
(c) Regardless of whether you do or do not hold USAEYES’ CRSQA certification, will we find your response to http://www.usaeyes.org/lasik/library/lasik-tough-questions.pdf (or something like it) on your website?
38. Are there any near-future opportunities where I can watch you perform an ICL™ procedure?
39. In the immediate days after the ICL™ surgery, what’s your protocol for handling emergencies & complications?
· Does your post-op instruction sheet demarcate what circumstances dictate a phone call to you vs. a trip to the emergency room?
· Does your post-op instruction sheet itemize symptoms (i.e., high Intra-Ocular Pressure = ______________) that we should be on the lookout for?
· To contact you directly, are we getting your cell phone, or going through an answering service that can reach you 24/7?
40. Can energy from the PI’s laser (or surgical trauma if done w/ instruments) induce a change in the cornea as the energy passes through it on the way to the Iris? If yes:
· Is that change typically to the degree of myopia or astigmatism?
· Is that correctable by the ICL™?
· Does that mean you always do the Final Measurements Exam after the PI?
41. As high myopes, we’ve been briefed about the higher risks of retinal detachment due to congenital weak spots in/around the retina where it attaches to the underlying tissue. Are there any analogous phenomena such as congenital thin areas at random locations on the Iris? If so, can the PI holes, if created on/near those thin spots, end up leading to catastrophic tears in the Iris? Do you use testing or inspection to eliminate this risk before the PI? Would a 12:00 ‘slit’ PI aperture (as opposed to 11:00 and 1:00 holes) put us more/less at risk for this?
42. Do you need written or verbal concurrence from my regular O.D. that my vision has been stable for ___ years?
43. Will the actual ICL™ procedures be done for both eyes on the same day (bilateral), separately spaced ___ days apart, or is it the patients’ choice? What are the advantages/disadvantages of each approach? If separated by ___ days:
(a) How do you pick which eye goes first: by degree of myopia or by dominance?
(b) What are the challenges (and solutions) to functioning at work & home with the depth-perception issues that may result from having one eye corrected and the other eye looking through a thick eyeglass (assuming the patient is unable/unwilling to wear a contact lens in the 2nd eye)?
44. What protects my vision if …..
· your facility experiences a power outage during my surgery?
· your facility experiences an earthquake during my surgery?
· I sneeze during my surgery? Is this mitigated by patients wearing a nose-clip (to force them to breathe through the mouth) or a surgical mask?
45. On the day of my surgery, how many spare lenses (or spare pairs of lenses if surgery is bilateral) of my prescription ICL™ lenses will be on hand?
46. Do you fold the lenses & load them into the injectors yourself?
47. Do you use the zero-manipulation instruments / technology as shown in the following video?
http://www.youtube.com/watch?v=Zx0C1wKF7E4
48. Will you use Occucoat viscoelastic? (reportedly the least risk of cataract formation, as of this writing)
49. The manufacturer’s literature states that during ICL™ surgery a gel-like substance will be placed inside your eye.
(a) What’s it for? What does it do that the normal anterior/posterior chamber fluids don’t do?
(b) Where do the normal anterior/posterior chamber fluids go during this time? The gel-like substance must be displacing them somewhere.
(c) How do you ensure that no residue from that gel -- or air bubbles introduced during the surgery -- remains in either anterior/posterior chambers, resulting in the creation of a new kind of man-made floater that interferes with post-op vision?
50. Do you perform your ICL™ procedures in a surgical suite in your office or do you rent an Ambulatory Surgical Center?
(a) Ignoring economic/profit issues that are strictly your business, why is it in my best (medical) interest to favor the arrangement you’ve chosen?
(b) If you use an ASC, are the people who assist you in the surgical room trained employees of yours or are they on staff to that facility?
(c) When was the last time your surgical facilities (in-house or ASC) were inspected & approved by http://www.aaahc.org/?
51. A highly-regarded Beverly Hills Lasik surgeon boasts about getting superior results (and/or fewer complications) because he goes above-and-beyond in terms of …..
· Calibrating his equipment more often (after every procedure) than “industry standards” demand
· Keeping his surgical room more dust-free/air-filtered than “industry standards” demand
· Keeping his surgical room more tightly-controlled in temperature & humidity than “industry standards” demand
· when doing Bilateral surgery:
ü Using separate surgical gloves for -- and re-scrubbing up in between -- each eye
ü Using separate surgical instruments (especially Keratome blades) for each eye
(a) To what degree do such policies help mitigate ICL™ risks and optimize ICL™ outcomes & do you follow them during ICL™ surgery?
(b) Do you follow these policies when doing post-ICL™ Lasik touch-up surgery?
52. After the ICL™ surgery (and/or Lasik touch-ups) what are the risks that I will need to take -- or be advised/recommended to take -- any oral and/or topical medications indefinitely (with no end in sight, at least until the ICLs™ come out due to cataracts)? i.e., Optimal Eye, Flaxseed Oil, Blur Relief, etc., How expensive are these medications? [This is separate from the earlier question about using pupil-constrictor medications to combat Halos]
53. Does the Iris try to repair itself by "tightening up" the PI holes over time? If so, at what intervals (___ years) should we expect this to happen? Presumably, you, the ICL™ physician, will want to open them up again with another couple of blasts of the PI laser to mitigate elevated intra-ocular pressure. What are the (post-warranty) costs for this?
54. When it comes to the (long-term) after-care monitoring of all the various post-ICL™ risks, how much is done by my regular O.D., and how much is done by you, the ICL™ surgeon? What are the post-warranty costs for the later? i.e., We know that O.D.’s can check for glaucoma (elevated intra-ocular pressure) & cataracts (natural lens opacities), but it isn’t obvious if they can measure things like endothelial cell loss. Will the O.D. require any non-standard equipment to do endo counts and/or make other routine eye exams around the ICLs™?
55. We know there are short-term post-op restrictions on rubbing the eyes, but what are the long-term restrictions, if any? What are the risks that doing so (i.e., tired at the end of a long work day) can ….
(a) …. tweak the positioning -- and therefore the effective corrected vision -- of the ICL™ sitting in its chamber (or disturb the post-enhancement Lasik flap)
(b) …. worsen the endothelial cell loss rate? Does rubbing the eyes harm a person’s endo count even in the absence of an ICL™ or IOL of any kind?
How do we quantify the degree-of-vigor in judging acceptable degrees of eye-rubbing?
1. Why are there so many questions?
As an engineer, I’m trained to shine a light in all the dark corners of the room.
If you have survived a normal lifetime’s worth of car rides, boat trips, airplane flights, and medical procedures, then you owe your life to the concept of the Design Review, an engineering tool where tough questions get methodically asked & answered now to avoid problems in the future. Surprises are for birthday parties, not eye surgery. This document can be the basis for your Design Review of the ICL™ product.
2. Too many of the questions here are irrelevant to my situation, and since copying and re-formatting HTML is a painful process, is there a way I can get my own copy of this document so I can delete, add to, edit, re-order, or re-word various questions to create my own list that suits my specific concerns?
Yes, most potential ICL™ patients do NOT care about many of the questions listed here (but each question could be meaningful to somebody, somewhere, sometime). I fully expect you to treat this document as a buffet, and pick the handful of issues that matter to you. The links below will allow you to do just that:
Microsoft Word (2007) ... change extension to *.docx after downloading
Microsoft Works (versions 6 to 9)
Naturally, the reader will run the requisite virus-scan checks as necessary when downloading files from people they don’t know (i.e., me).
I’d also add that -- when creating your own document -- a customized ordering of questions, starting with most important and ending in least important, can be very useful in clarifying your own thinking about what key characteristics are going to play the biggest role in selecting your doctor.
3. I’ve edited this list down to the bare essentials that I care about, but the physicians I speak to are rolling their eyes at the quantity of questions, and have asked me to pick which ones are important.
You already picked the ones that are important. Ask the doctor which parts of your eyes are important.
Ask the doctor if he has an ICL™ FAQ page on his website. If not, why not? If yes, does it have original content -- perhaps answering many of the generic questions posed here -- or does he merely regurgitate the manufacturers’ marketing materials? If the later, whose fault is that?
This is elective surgery. You do not have to tolerate a lack of information.
4. I seem to be a borderline case between Lasik & ICL™ (bad myopia, but thick corneas), and have seen a number of refractive surgeons, half of whom are recommending Lasik, and half recommending ICL™ ….. and some of the doctors steering me to Lasik are ICL™-qualified! I’m confused. Is there something else going on here?
Different refractive surgeons, both offering Lasik & ICL™, could make different levels of profit based on:
· the doctors’ equity/debt ratio in his present Lasik machine(s)
· the royalty fees the doctor has to pay the laser manufacturer every time he burns a cornea
· the cost of the ICL™ lenses …. which may vary over time with demand, labor costs, material costs, and the manufacturers’ production, test, & quality-control efficiencies
· the physicians’ economics in renting an ASC vs. having his own in-office surgical suite
What that means is that even though the cost to the patient of getting ICLs™ is generally about twice (as of this writing) the cost of having Lasik, it does not follow that there is any correlation in the profit to the doctor. It is possible that these economic variables might influence which procedure different physicians might recommend for you.
As a purely fictional example, consider Doctor A & Doctor B, two refractive surgeons equally qualified and experienced in both ICLs™ and Lasik. Doctor A uses his own in-house surgical suite for ICLs™, but has just taken out a loan on his brand-new laser. Doctor B rents an ASC for his ICL™ procedures, but owns his laser free & clear. You’re not to be surprised if you get different recommendations from each doctor. Only the physician knows how his recommendation is a function of best-interests-of-the-patient medical opinion vs. profit motive. This is why you’re advised to visit a lot of refractive surgeons to get a lot of opinions, and, more importantly, a lot of experience in judging them.
5. I don’t see an email address on this webpage. How can I make comments/questions/suggestions to the author of this document?
Post a message to one of the following groups (which I read regularly) and it should get my consideration:
http://health.groups.yahoo.com/group/piolusers/
http://www.usaeyes.org/ask-lasik-expert/ (in particular: the “Thinking About It” section)
I don’t provide a direct email address here, because the USAEyes moderator is sensitive to outside links that provide ways of communication that bypass their message board, and I value participation on that site.
This webpage is not affiliated with, nor endorsed by, any company or physician mentioned herein. All content is the work & opinion of the author. All copyrights and trademarks are the property of their respective rights-holders.
Last Update: November 28, 2008