CK: A One-Year Retrospective
What I've learned after performing more than
600 conductive keratoplasty procedures.
BY GLENN H. STRAUSS, M.D.
Immediately following FDA approval of conductive keratoplasty (CK) in April 2002, I was excited about the potential of this new, minimally invasive hyperopic procedure that might rescue my refractive practice from the doldrums. Sure enough, my first patients were excited about this nonlaser procedure that could decrease their dependence on glasses -- possibly including their reading glasses. An initial marketing push and PR focusing on the reduction of presbyopic symptoms generated a tremendous response.
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How CK Changes the Cornea |
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The mechanical effects of CK appear to optimize the prolate curvature of the cornea. The band of circumferential tightening (which is centered about 3.5 mm from the center of the cornea, with a width ranging from 1.5 mm to 3.5 mm, depending on the number of treatment rings applied) creates four distinct zones on the cornea:
These changes result in the patient having minimal refractive overcorrection initially. This causes a marked improvement in near vision, while minimizing any loss in distance acuity. To achieve the maximum benefit, the final result should include a small amount of induced myopia in one eye (not as much as would be necessary for a standard monovision type correction.) In our practice, the incidence of undercorrection has been about 4%. These cases seem unlikely to achieve further improvement with more surgery.
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Over the course of the past year, I've treated more than 600 patients with CK. In fact, CK has become the most frequently performed refractive procedure in my practice. Paradoxically, it's also increased our LASIK volume, possibly because some patients who come in to investigate CK discover they're not ideal candidates; many end up electing to undergo LASIK instead.
As a result of this experience, my confidence in the procedure has grown and I've learned a tremendous amount about its nature, limitations, and value. Here, I'd like to share some of what I've discovered.
More Than a Refractive Procedure
One of the biggest lessons I've learned is that conductive keratoplasty doesn't simply correct hyperopia. In fact, overall, I've found the most powerful application of CK to be for the correction of presbyopic symptoms. In my CK patients, who average 56 years of age, using the procedure to induce a small amount of myopia in one eye and emmetropia in the other -- less than a 1-diopter difference between the eyes -- has caused marked improvements in reading acuity. As you can see from the data in the two tables to the right, this trend is out of proportion to the degree of induced myopia. It suggests that CK is accomplishing more than a refractive endpoint can explain.
Because this degree of myopia is much less than the amount of myopia that could cause a disturbing monovision effect, the term "blended vision" has been coined to describe this system to patients. Even failed monovision contact lens wearers are frequently highly satisfied with the results of "blended vision."
Not Your Typical Refractive Patients
The second lesson that I've learned is that CK patients are quite different from my LASIK patients. Specifically:
- They tend to be older (average age: 56).
- Their main complaint tends to be that they're tired of their reading glasses, not a refractive distance complaint.
- These patients are oriented towards functional improvement rather than seeking a specific vision endpoint such as 20/20.
- Unlike LASIK patients, who expect the doctor to work miracles without help from the patient, CK patients tend to be willing to participate in the process of obtaining good acuity. If properly educated, they see CK as an opportunity to overcome the effects of aging rather than a way to fix a disease or condition. They're willing to work with the limitations of this new tool, by adjusting reading distance and lighting to get the result they want.
Three other characteristics set these patients apart:
- They're usually new to eye specialists. Prior to CK, these patients simply purchased over-the-counter reading glasses and tolerated decreasing distance acuity.
- Unlike myopic patients, who often have learned to deal with contact lenses early in life, these patients are frequently unwilling to try contact lenses.
- CK patients are wary of complications, but they're willing to take the risk that the procedure might not work.
The Right Patients = the Best Outcomes
Rather than trying to expand its indications, my experience has also taught me that there's a definite advantage to focusing on patients who are ideally suited for the CK procedure. Based on our experience, we primarily offer CK to patients who:
- are 45 years of age and older
- are in the -0.5 to +2.00 diopter range
- have up to 1.00D of corneal astigmatism
- have good correctable binocular acuity and minimal lenticular cylinder
- show less than 2+ nuclear sclerotic changes.
Offering CK primarily to these patients has decreased my re-operation rate to 8%. It has also decreased the incidence of induced astigmatism to between 1.5% and 2%. (Patients undergoing re-operation for induced astigmatism can be improved in 80% of the cases.)
To further increase the likelihood of a good outcome, I use what we call the "loose lens test" to determine which of these patients are most likely to be satisfied with the results of CK. (For a complete description of this test, see "Weeding Out Poor Candidates," on the facing page.)
Coincidentally, it appears that LASIK patients and pseudophakes will be excellent candidates for CK. I've seen a growing number of presbyopic LASIK patients who are now enjoying good vision following CK.
Risks and Limitations
As with any new procedure, we're also exploring the limits and risks of CK. Observations I've made during the course of the past year include:
- Most surgeon-related problems will probably occur in the first 40 patients. For example, inducing up to 2.5 diopters of cylinder in 20% to 30% of the first group of patients is not unusual. This cylinder does tend to decrease with time but may need to be addressed within the first 6 to 9 weeks by additional treatment.
- Patients with extensive hyperopia (greater than 2 diopters) tend to obtain less than the usual benefit from the conductive keratoplasty procedure. My mother-in-law, who is a bilateral +3.00 hyperope and 72 years old, was one of my first cases. She received a 32-spot treatment in both eyes, and within 3 days was 20/25 at distance and J3 at near. This was an outstanding result, but if I had known then what I know now, I wouldn't have chosen her to be one of my first cases.
- This procedure is not indicated for patients who don't have good binocular acuity with good stereopsis.
- Although CK is a powerful tool for correction of astigmatism, I'm not yet convinced that it's going to become a primary astigmatic procedure. Accurate axis alignment and reproducibility continue to be challenges. Correcting more than 1.5 diopters of corneal astigmatism is currently more of an art than a science.
- CK doesn't seem to be useful for the correction of hyperopic shift in RK patients. Initially I thought this would be a possible application, but my experience has been discouraging.
- One important contraindication for this age group is the presence of significant nuclear cataractous changes. (Cortical cataracts seem to be less of an issue.) Following CK, two patients complained of symptoms relating to nuclear sclerotic cataracts, even though preoperatively they had been asymptomatic. It's possible that the slight spherical aberration induced by CK added to aberration caused by the cataract. However, both patients underwent successful cataract surgery and achieved good results, with no adjustment made in the IOL calculation.
- More study will be needed to determine long-term stability. Current data suggests that stability is good compared with other thermokeratoplasty procedures and H-LASIK; 3-year FDA data show a reported drift of +0.25 diopters per year. However, I prepare all my patients for the eventuality of change. Generally, I tell patients that they can expect 3 to 4 years of effectiveness.
Off To a Great Start
My one-year post-op patients are now starting to present for follow-up. They report general satisfaction with their vision and continue to refer other patients for treatment.
Conductive keratoplasty has been a valuable addition to my refractive practice. I've found it rewarding to work with these patients and I anticipate long-term relationships with many of them, since this procedure requires upgrades after several years. Word of mouth has been strong, but marketing the key concepts has also been an important factor in generating volume.
After one year, CK has come into its own in my refractive practice. I look forward to what it will teach me over the next year.
Dr. Glenn Strauss is a board certified ophthalmologist specializing in cataract surgery, LASIK vision correction, and CK. He has been a principal investigator in research involving the healing process in refractive surgery, and was the first ophthalmologist in the state of Texas to perform the conductive keratoplasty procedure.
Weeding Out Poor Candidates |
To give patients a good idea of what they can expect, I've developed a "loose lens test." I help the patient try four lenses (+0.75, +1.50, +2.00, and +2.50) to approximate the titratable effect of CK treatment. The lenses can't exactly duplicate the end result, but it's possible to approximate a desirable outcome by setting up appropriate conditions. For the test to work well, I follow several rules:
Within 4 to 5 minutes, patients find a combination they like. If they're satisfied (they're often excited) we proceed. As long as the conditions listed above are followed, the test has a very high predictability rate. Out of the more than 600 patients who've had CK after trying this, only one patient was dissatisfied with the actual result. (Surgeons who don't follow these conditions report much less satisfactory outcomes.) One of the advantages of this test is that I can tell patients they can expect a result as good as what they're experiencing -- or better. I've found that if they like the effect created during the test, they love the actual result of the procedure. The test lets the patient experience a functional binocular endpoint without overpromising the results. Only 5% to 10% of tested candidates aren't satisfied with the sample result; they usually want better near acuity than J3. (This is in contrast to monovision candidates, who tend to be unhappy with their distance vision.) If they can't find a satisfactory combination, I tell them that CK may not be the best alternative to meet their needs. The fact that so few patients don't like the sample outcome is one reason CK has been so successful in my practice. |
Looking at Stability |
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More than a dozen papers and posters on conductive keratoplasty (CK) were presented at this year's ARVO and ASCRS meetings, including 2-year results from the U.S. multicenter hyperopia clinical trial. Of interest to many surgeons as they attended the talks was the stability of the procedure over time. In the trial, 401 eyes have been treated, and 2-year data is available on 378 eyes (94%). On stability, the data show: According to several clinical investigators who have also been performing CK outside the trial since FDA approval last year, stability over time is good. "I've done CK for almost 5 years, first as part of the trial and now outside the trial," says Marguerite McDonald, M.D., who was the second U.S. surgeon to perform the procedure. "My stability data compare beautifully with the trial data." Dr. McDonald says she uses the example of entertainment icon Cher and facelifts to explain the stability aspect of CK to her patients. "It makes them smile, but it makes the point very clearly. I tell them that hyperopia tends to slowly increase whether we operate on you or not, and whether we use CK or excimer laser to treat your hyperopia. Cher is 57 years old and has had several facelifts. If she stopped after only one, she would still look younger than all of her friends at her high school reunion. However, she wants to continue to look young, so she's had several facelifts. "CK is an anti-aging procedure. In 5, 7, or 10 years, we may have to treat you again. We can turn back the hands on the clock but we can't stop it from ticking, and you'll never lose the benefit of the surgery. Even if you only have one CK procedure, it will give you great benefits. If you choose not to enhance it years from now, you'll still be ahead of the game." Dr. McDonald says her patients see better than she would expect from their refractions. "Even if they've crept as much as a diopter after 4 or 5 years, they still see well at distance and near," she says. "We have lots of people now who come back after just about 5 years and haven't asked for enhancements. So I think we're looking at stability closer to 7 years and possibly beyond." In February, enrollment in the Phase III FDA clinical trial of CK to treat presbyopia was completed. Refractec, the maker of the Viewpoint CK System, expects to file for pre-market approval of the presbyopia indication by the end of this year. -- Ophthalmology Management
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