March 14, 2014
My name is Laurén Doamekpor, and I am a senior fellow at the National Research Center for Women & Families. Our non-profit research center assesses medical and scientific data and provides objective health information to patients, providers and policy makers. Our organization does not accept funding from medical device companies, and therefore I have no conflicts of interest.
We carefully reviewed the data provided to you by the FDA and want to share our research and ethical concerns.
Myopia and astigmatism are extremely common and we approached today’s meeting with hope that the evidence would be solid so that people could benefit from this device. I’m sure you did too. However, we have 2 substantial concerns:
1) We have reservations about the effectiveness of this device. There are many methodological problems. The study’s protocol deviations include device modifications, the use of invalidated survey tools, unstandardized methodology, out-of-window visits, as well as missing data.
Although the sponsor attempts to address the out-of-window visits by conducting comparative analyses, the analyses do not take into account other deviations that may introduce bias. That makes it impossible to draw conclusions about the effectiveness of this device.
Unfortunately, the sponsor has a history of violations for this clinical study, including the initiation of a study protocol without FDA approval. The sponsor has clearly shown little respect for the approval process. For that reason, I don’t think we can give them the “benefit of the doubt” about the various methodological shortcomings and violations in this study.
2) We are also concerned that endothelial cell data was not collected in the Visian TICL study. That was absolutely essential to assess the long-term safety of this device. The FDA’s review noted that the sponsor’s previous myopia ICL post-approval study showed that 6% of eyes experienced significant endothelial cell loss between 4 and 6 years after surgery.
Loss or destruction of endothelial cells is permanent and significant loss can lead to corneal edema or blindness. Would you be willing to take that chance, if you knew about it? Would your patients appreciate your recommending this device, if it caused blindness a few years later?
The sponsor proposes to collect data on endothelial cell loss in a post approval study. Think of the millions of Americans who could be harmed by this device in the meantime. Unless we have better long-term data to warn patients of the exact risks, putting this device on the market would be unethical. And it could certainly harm the patients’ trust in the FDA and in ophthalmic surgeons.
Researchers at the major medical schools across the country have studied the track record of companies in complying with FDA’s post-market study requirements. Unfortunately, it is clear that companies take their time in doing post-market studies and often fail to provide the incentives needed to keep patients from dropping out of longer-term studies.
Please protect patients and the reputation of the FDA by voting to require follow-up of the TICL cohort BEFORE this device is approved.
The FDA Advisory Panel voted 6-0-3 (yes, no, abstain) that the benefits of the Visian Toric Implantable Lens do outweigh the risks for use