Epithelium-on cross-linking prevents vision loss with lower risk, faster recovery
Click Here to Manage Email Alerts
Roy Rubinfeld and I share a unique connection.
I first visited him at his office in Washington, D.C., in 2008. It turned out that this was the same ophthalmology practice, started by Mel Alper, MD, where my grandmother worked as a secretary in the 1950s (well before Roy’s time there). While in high school, my father — Henry Trattler — spent time with Dr. Alper and learned about ophthalmology. He eventually became an ophthalmologist, and I followed in his footsteps.
Source: William B. Trattler, MD
Prior to meeting with Roy, I was an investigator in the original FDA clinical trial for epithelium-off cross-linking. While at a conference in Washington, D.C., I visited his practice, where he discussed the development of a new clinical trial for CXL.
I was greatly impressed with Roy’s ingenuity and scientific expertise. He identified an FDA-cleared UV light source that was being used for dermatology, which was modified so that simultaneous bilateral UV light treatments could be performed. He worked with a photochemist, medicinal chemist and others international experts to understand the pathways and physics of cross-linking, and they determined that pulsing the UV light in a certain patented way would provide a safer and more robust cross-linking effect, with significantly less energy exposure. Finally, Roy worked with a team to develop a non-disruptive set of depot delivery sponges and a more advanced formulation of riboflavin that could rapidly and effectively penetrate into the deep layers of the cornea without removal of the epithelium.
We worked with several institutional review boards to start the CXLUSA clinical trials, which started in 2009. My role was to help develop the protocol, as well as identify clinical trial sites. A total of 17 sites were part of the clinical trial, and we performed our first epithelium-on CXL procedures in May 2010. Of interest, the CXLUSA clinical trial allowed for either epithelium-on or epi-off CXL. The concept of epithelium-on CXL was met with skepticism by a number of the other investigators in CXLUSA. They were not sure if it was going to work as well as epi-off. However, once they saw the results from this unique proprietary system, the sites switched to epithelium-on CXL in 100% of their cases, as they noted that the epithelium-on procedure was just as effective or more effective as epi-off, but allowed for simultaneous bilateral treatment, rapid recovery and very low risk.
From 2009 to 2016, there was no FDA-approved technologies for CXL, and the CXLUSA investigators were the main sites performing cross-linking in the U.S. during this time period. Many of these patients continue to come back for follow-up visits, and it has been incredible to see that many of the patients experience continued improvement in their vision and corneal shape over this time period. Our re-treatment rate following epithelium-on EpiSmart CXL has been less than 1%.
Currently, the CXLUSA technology (now called EpiSmart) has received significant funding, allowing for a phase 3 FDA clinical trial that hopefully will lead to approval of epithelium-on CXL. Glaukos has also been working hard to bring epithelium-on CXL to the U.S. Once commercially available, my expectation is that we will see a rapid switch to epithelium-on CXL.
Reflecting on my work with Dr. Rubinfeld, I feel very lucky that he helped develop a number of novel key technologies and innovations to the CXL procedure that have allowed us to help so many patients with keratoconus and post-LASIK ectasia. While there has been some skepticism because the technology is not yet commercially available, I am quite confident that it will become very popular for helping patients with keratoconus. I congratulate Roy on his vision and perseverance, and hopefully this simultaneous bilateral epithelium-on technology with pulsing UV light will become available in both the U.S. as well as internationally in the next few years.
Click here to read the Cover Story, “Rubinfeld leads disruption in corneal cross-linking.”
- For more information:
- William B. Trattler, MD, is a Healio | OSN Associate Medical Editor.
Collapse
Read more about
Click Here to Manage Email Alerts