WHY WE DO NOT RECOMMEND THE EPI-ON CROSS LINKING PROCEDURE
- No scientific proof has ever been presented in laboratory or animal studies on the efficacy and safety of the epi-on procedure which has to date been done by only a handful of doctors all from private clinics or practices with no supportive scientific background.
- The epi-off procedure which is performed by most surgeons worldwide is the only procedure which has been shown to be safe and effective in treating humans and has been used for up to 8 years in Europe now.
- Advocates of the epi-on procedure cross reference data, which has been published for the epi-off procedure suggesting safety and efficacy. Since the treatments are different the findings from one method does not apply to the other method.
- The epi-on procedure does provide some biomechanical effect but laboratory research by Wollensak one of the pioneers of the procedure has demonstrated that it is only 20% as effective as the epi-off procedure.
- The FDA in the United States to date has not approved collagen cross-linking; there is some question as to whether it might be ethical to offer this treatment without IRB oversight. IRB oversight does afford patients an extra layer of protection for a procedure which to date is still regarded as experimental in the USA despite its safety and efficacy record in Europe.
- The epi- off procedure is the only procedure which to date has been demonstrated result in continual corneal flattening over time in patients with Keratoconus. This has never been demonstrated with the epi-on procedure.
- We have now seen enough patients in our clinic who either had a failed epi-on procedure or have not been happy with outcome of their epi-on procedure to make us very skeptical about the advertized efficacy of this procedure.
- Theepi-off procedure has been demonstrated to be very safe with minimal complications and minimal discomfort in our hands so why would we recommend an unproven treatment to our patients when we know the proven treatment (epi-off) procedure works well.