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Cornea transplant policy out-of-step with current evidence

A US Food and Drug Administration (FDA) policy that automatically disqualifies men who have had sex with men in the preceding five years from donating corneas is not justified by current evidence, research shows.

The policy dating back to 1994 has cost eye banks an estimated 1,600 donated corneas in 2018, according to research presented by Dr Michael Puente Jnr, an ophthalmologist at Children’s Hospital Colorado.

Presenting his findings at the virtual Association for Research in Vision and Ophthalmology meeting in May, Puente believes hundreds of corneas were never donated because MSM status (men who have sex with men) were turned away due to an antiquated policy.

As it currently stands, HIV tests administered to all potential donors in the US are more accurate and have a shorter window than tests available when the FDA policy was made in 1994.

If an HIV-positive donor “slips through the cracks,” the risk of HIV transmission through a corneal donation is still low, Puente said.

Since 1985 there have been 10 reported cases of corneal transplants using tissue of donors who were HIV-positive but no recipients who received those corneas became HIV-positive.

According to the researchers, the FDA and the Eye Bank Association of America do not require eye banks to specifically record if a donor is turned away due to MSM status, so they administered a three-question survey to each eye bank to determine the accuracy of their records.

Each eye bank was asked if it kept records of potential donors disqualified specifically due to MSM status and, if so, how many were disqualified in 2018 due to MSM status. The researchers also asked how many eyes were recovered at each eye bank in 2018.

Of the 65 total eye banks, 54 responded to the survey. In total, 24 eye banks kept records of potential donors who were disqualified because of their MSM status. The other 30 said MSM donors that were turned away were labelled as “high risk” in their records, Puente reported.

Of the 24 eye banks with records, 360 potential donors were turned away due to MSM status, equalling 720 corneas. These eye banks were responsible for more than 46.2% of all corneas recovered in the US and Canada in 2018, leading to an estimate of 1,600 corneas disqualified in 2018, Puente said.