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US surgeon performing cross-linking with informed consent, without FDA approval
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KIAWAH ISLAND, S.C. — A surgeon here reported he has begun performing corneal collagen cross-linking in the United States for cases of keratoconus and ectasia with proper informed consent but without U.S. Food and Drug Administration approval, and he encouraged his colleagues to become involved with the treatment.
"Collagen cross-linking is available in every country in the world other than the United States," Eric D. Donnenfeld, MD, said at Kiawah Eye 2011. "I think that keratoconus is now a treatable disease, and no one should need a corneal transplant any longer who has keratoconus.
"So my personal choice ... is that I have made the decision that I am going to do corneal cross-linking. I have purchased a unit from Europe that is approved in Europe for cross-linking. This is not FDA approved, and I tell every patient that it is not FDA approved, and I have an informed consent," he said.
A small portion of the informed consent, which Dr. Donnenfeld read aloud, states: "Your options are to continue with current and surgical treatments such as Intacs implantation or full-thickness corneal transplant surgery; join an ongoing study; wait for an eventual FDA approval on cornea cross-linking; or seek treatment in another country or allow me to do it in a non-FDA approved treatment."
Dr. Donnenfeld said that cross-linking also eliminates corneal ectasia as a risk factor for LASIK and PRK.
"[Cross-linking] really gives us a lot of security that this dreaded complication no longer is as serious as it was in the past," he said.
Dr. Donnenfeld noted that corneal cross-linking has a track record of more than 15 years in Europe and that there are 16 currently or concluded clinical trials taking place in the U.S.
He said that he believes there is no reason for any randomized clinical trials for cross-linking, and he and his partners have already refused to take part in trials.
"In my estimation, that ship has already sailed: I am not going to be subjecting my patients to a clinical trial where they have a 50% chance of being in a control group," he said. "It makes no sense."
Dr. Donnenfeld performed 75 cases in an FDA trial, and he has now done 300 cases in the past year. "We think it's our obligation to provide this service for patients, and we're very comfortable with that," he said.
He said that corneal cross-linking has presented the first treatment for keratoconus other than corneal transplant surgery.
"I think it's a procedure that deserves to be considered by all of you, and if any of you have a patient with keratoconus or ectasia, either find someone in your community or send them to New York if you like, and we would be happy to treat them," he said.
- Disclosure: Dr. Donnenfeld has no financial interest in corneal cross-linking technology.
There is some significant medical-legal liability with the approach of using a non-FDA approved medical technology on patients. I reviewed a medical-legal case of a surgeon who brought in non-approved phakic IOLs from Europe prior to U.S. approval, and one patient developed significant complications. The surgeon lost a major legal case. For cross-linking, there are currently 40 or so locations in the U.S. conducting clinical trials with appropriate regulatory oversight, and these locations are listed on clinicaltrials.gov. Non-FDA approved cross-linking devices are being used under the proper FDA regulations (as part of IDE clinical trials, etc.). Dr. Donnenfeld is a close friend, one whom I respect and trust, but in this situation, there is major legal risk. I recommend going to the FDA website to learn how to initiate a clinical trial if someone is interesting in performing cross-linking legally in the United States.
– William B. Trattler, MD
OSN SuperSite
Board Member
Disclosure: Dr. Trattler is a consultant to CXLUSA.
Dr. Donnenfeld is providing a very valuable service to patients. Without cross-linking, many of these patients would eventually require corneal transplantation for visual recovery. I have referred several patients to him, and he has provided them excellent care at a very reasonable price. Dr. Trattler points out that there are sites with ongoing IDE clinical trials. However, many of these sites are significantly more expensive and not an option for my patients. Cross-linking has become the standard of care for mild to moderate keratoconus and corneal ectasia for most of the rest of the world and should be in the U.S. as well. I applaud Dr. Donnenfeld for his work and leadership in this field.
– Edward J. Holland, MD
OSN
Cornea/External Disease Board Member
Disclosure: Dr. Holland has no
financial disclosures to report.