Tracking Custom Cornea's Early Clinical Outcomes
Alcon's LADARVision CustomCornea not only produces excellent visual acuity, but also brings revolutionary changes in patient satisfaction.
By Bill Tullo, O.D., F.A.A.O., New York

With significantly improved outcomes and unprecedented patient satisfaction, LADARVision CustomCornea has made a transformational impact at TLC Laser Eye Centers in just months.

At TLC Manhattan, we embraced Alcon's LADARWave CustomCornea wavefront system as soon as it became available to us in April 2003. The outcomes have shown a significant leap over standard LASIK for quality of vision. At TLC Manhattan we've seen about a 10% increase in patients with 20/20 vision after treatment.

But this isn't the only significant result. In the last 6 years, surgeons at TLC Manhattan have performed more than 25,000 conventional procedures. When we began using the LADARWave CustomCornea device, it was clear immediately that we'd made a major change. In just 1 day, more patients said, "This is the best I've ever seen," than in the entire month before. With the LADARVision CustomCornea procedure, the number of patients reporting this level of satisfaction jumped from about 10% to more than 50%. I knew we were doing something better for patients than ever before.

Better clinical outcomes

As of September 2003, TLC Laser Eye Centers nationwide performed more than 40% of their LASIK procedures as custom LASIK. At TLC Manhattan more than 70% of our procedures are wavefront-guided LASIK, and we use the LADARVision system on more than 60% of procedures. The volume of LADARVision CustomCornea varies at each TLC center. Access to LADARWave aberrometers is still a limiting factor at some centers. This, along with the fact that many prescriptions don't qualify for CustomCornea, limits the ability to perform CustomCornea on all patients.

Even so, the improvements in our outcomes have been significant. Not only do 10% more patients achieve 20/20 visual acuity with the procedure, but after more than 1,000 custom LASIK procedures at TLC Manhattan, most patients report improved night vision after surgery. We've seen no difference in complications with the new procedure vs. traditional LASIK.

Enhancement rates throughout the industry with conventional LASIK are between 5% and 15%. LADARVision CustomCornea will likely reduce these numbers significantly. After the first 6 months, fewer than 1% of patients receiving LADARVision CustomCornea at TLC Manhattan have requested an enhancement. Without a second round of laser treatment, there's obviously less potential for problems or complications.

In the past, a small percentage of conventional LASIK patients experienced glare, halos and other night-vision problems. So far, we've had no night-vision complaints from our CustomCornea patients. In fact, we've begun correcting visual complaints of glare, halos, starbursts and double vision for previous LASIK patients. I feel this is the most exciting area for using the LADARVision system.

Improved patient satisfaction

We've always enjoyed a high level of patient satisfaction at TLC Manhattan with conventional LASIK. Even so, the increase in patient satisfaction after introducing CustomCornea to our centers has been notable. Along with a 10% increase in patients achieving 20/20 vision, we've had more than a 50% increase in patients saying that their vision was "better than ever."

Perhaps the most interesting patients were the few who achieved uncorrected vision of only 20/25 or 20/30, yet were extremely satisfied with their vision. This was a major change compared with those who achieved the same visual acuity with standard LASIK. It highlights the fact that visual acuity is only one of the benefits of LASIK surgery with the LADARVision system. It's clear that aside from visual acuity, other factors affect patient satisfaction.

Our results in visual acuity and patient satisfaction led us to an important conclusion: We can't judge the success of CustomCornea surgery merely by the percentage of patients who achieve 20/20 vision or better as we did in the past with traditional conventional LASIK. In fact, our results show that it isn't necessary for patients with CustomCornea surgery to achieve 20/20 vision to be satisfied with the results.

We need to redefine "quality of vision" with other measurements. Patient questionnaires and contrast sensitivity testing are two ways we can improve our measurement criteria.

In the next year, ongoing research at TLC and elsewhere will give us a common language and measurement tools necessary for evaluating quality of vision among refractive surgery patients.

An exciting future

Rarely do we encounter a new technology that produces such significantly better results than the status quo as does Alcon's LADARVision CustomCornea procedure.

We were impressed with the 1-day results, but the results at 3 months and 6 months were even more convincing. At 6 months, more than 96% of our initial CustomCornea patients have achieved 20/20 or better uncorrected visual acuity, and the results continue to improve. Based on our outcomes at TLC, I think any patient who meets the FDA-approved parameters should have CustomCornea.

Some of my colleagues ask why a patient should pay more for a procedure that gains only a 10% increase in achieving 20/20 vision. The answer is that the value is enormous in terms of quality of vision. At TLC, we're excited to explore a whole new dimension of vision quality with this first generation of the CustomCornea product, and we're anticipating rapid improvements in technology in the future.

Dr. Tullo is the clinical director of TLC Manhattan, and is a member of the Clinical Advisory Group for TLCVision.