A Report by the American Academy of Ophthalmology Ophthalmic Technology Assessment Committee Oculoplastics and and Orbit Panel: Jeremiah P. Tao, MD,1 Vinay K. Aakalu, MD, MPH,2 Edward J. Wladis, MD,3 Rachel K. Sobel, MD,4 Suzanne K. Freitag, MD,5 Jill A. Foster, MD,6 Michael T. Yen, MD7
Ophthalmology, May 2020, Vol 127, 689-695, © 2019 by the American Academy of Ophthalmology. Click here for free access to the OTA.
Purpose: To review the literature on the efficacy and safety of bioengineered acellular dermal matrix (BADM) grafts for lower eyelid retraction repair.
Methods: A literature search was conducted in the PubMed database initially in January 2018 and updated in July 2019 to identify all studies in the English language literature on the use of BADM grafts in eyelid reconstruction. The searches yielded 193 citations, and 15 of the 34 articles selected for full review met all inclusion criteria for this assessment. A panel methodologist then assigned a level of evidence rating for each study. Two of the 15 studies included were rated level II and 13 were rated level III.
Results: The definition of success varied, but lower eyelid position improvement using lower lid margin-to-pupillary reflex distance was the most common outcome measure. Other end points were the amount of lagophthalmos, cosmesis, exposure, reoperation, or complications, as well as prosthesis retention in anophthalmic socket cases. The surgeon-reported success rate of these outcomes ranged from 75% to 100%. Minor complications included cyst formation, infection, chemosis, pyogenic granuloma, and corneal abrasion. No serious complications such as blindness, anaphylactic reaction, or terminal disease transmission occurred. Of the 526 implants included for assessment in these disparate studies, 27 cases (5%) required reoperation.
Conclusions: No level I evidence was available, and the existing level II and level III studies have variable primary end points, study design limitations, and only short-term follow-up data. The current literature suggests that BADM grafts represent an implantation option for lower eyelid retraction repair. Short-term results are favorable, and the materials used may fill an important gap in care for patients for whom no acceptable alternatives exist, but long-term safety and efficacy remain unknown.
1Gavin Herbert Eye Institute, University of California, Irvine School of Medicine, Irvine, California
2Illinois Eye and Ear Infirmary, University of Illinois College of Medicine at Chicago, Chicago, Illinois
3Ophthalmic Plastic Surgery, Lions Eye Institute, Department of Ophthalmology, Albany Medical Center, Albany (Slingerlands), New York
4Vanderbilt Eye Institute, Vanderbilt University Medical Center, Nashville, Tennessee
5Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Massachusetts
6Ophthalmic Surgeons and Consultants of Ohio, Columbus, Ohio
7Cullen Eye Institute, Baylor College of Medicine, Houston, Texas