Umbilical Cord and Amniotic Membrane Allografts Improve Dry Eye

A recently FDA-approved umbilical cord and amniotic membrane allograft improved symptoms of refractory dry eye disease (DED) in patients who participated in a pilot study, say researchers who presented the study at the American Society of Cataract and Refractive Surgery (ASCRS) 2021 Annual Meeting, held in Las Vegas July 23 to July 27.

Amniotic membrane has been shown to improve DED, which has limited management options in cases involving refractory disease.

The researchers conducted a retrospective pilot study that included 3 patients with refractory DED who had not shown improvement in treatments with artificial tears, cyclosporine drops and/or topical steroids. They excluded patients who had undergone ocular surgery in the previous 3 months, were pregnant or used contact lenses. They also excluded patients with eyelid abnormality or active eye infection.

The investigators randomly selected 1 eye of each patient and used forceps to place cord tissue into that eye’s superior fornix until it dissolved, which occurred by 1 week. They compared best corrected visual acuity (BCVA), fluorescein pattern, mean Schirmer scores, and tear break up time (TBUT) in each patient’s treated eye and untreated eye. The researchers also used Dry Eye Workshop Study (DEWS), Ocular Surface Disease Index (OSDI), National Eye Institute (NEI) scale, Standard Patient Evaluation of Eye Dryness (SPEED), and visual analog scale (VAS) questionnaires to measure patients’ symptoms. 

At month 1 postoperative, mean Schirmer, TBUT and NEI scale had improved more in the treated eye than the untreated eye. Mean Schirmer score increased by 2 mm (treated eye) vs 0.7 (untreated eye). TBUT decreased by 2.7 seconds (treated) vs 2.3 (untreated). NEI scale was the same in both eyes preoperatively, but it was better in the treated compared to untreated eye postoperatively.

OSDI decreased by 2.7 (treated) vs 3.3 (untreated), and SPEED decreased by 1 (treated) vs 1.3 (untreated). VAS score decreased by 2.3 at week 1 and 2 at month 1 (treated) vs 2 at week 1 and 2.6 at month 1 (untreated). BCVA was stable within 1 line in both eyes.  DEWS was unchanged in both eyes.

No complications, discomfort or requests for graft removal were reported. Limitations of the study included limited sample size and lack of masking.

“This is a technically easy procedure with minimal risk and discomfort to patients,” the researchers report.

Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Vu PQ, Chamberlain WD, Nanji AA, Redd TK, Stutzman RD. Novel umbilical cord and amniotic membrane graft for dry eyes.  Paper presented at: American Society of Cataract and Refractive Surgery (ASCRS) 2021 Annual Meeting; July 12-27; Las Vegas, Nevada.