November 1, 2011 (Orlando, Florida) — An evaluation of a novel tissue adhesive has shown merit in helping reduce changes in cornea shape during clear corneal cataract surgery, probably because of improved wound closure. But, for now, the benefits of the approach come with the risk of endophthalmitis.
The study evaluating the ReSure Adherent Ocular Bandage (Ocular Therapeutix) was presented as a poster here at the American Academy for Ophthalmology (AAO) 2011 Annual Meeting by Gregory Pamel, MD, New York University School of Medicine in New York City.
Clear corneal cataract surgery has become the standard of cataract care worldwide. Even though the incisions necessary for the surgery are small, astigmatism change is possible, Dr. Pamel cautioned.
"We have observed for years that, although [postsurgical] refractive astigmatism changes are minimal, topographic and tomographic changes show significant irregular astigmatism near the incision site, which may affect visual function," the researchers wrote in their poster.
The study evaluated the tissue adhesive in 155 consecutive patients who had received a 3-mm corneal incision for the implantation of an intraocular lens. All patients received stromal hydration for wound closure. Some patients additionally received the tissue adhesive, which was prepared immediately before use and painted on the incision borders. After a few seconds to allow stabilization of the adhesive and sealing of the wound, the excess was sponged off. The outcome (cylinder change) was assessed by corneal tomography for up to 6.5 months.
At week 1 and months 1, 3, and 6, cylinder changes for patients receiving stromal hydration were 1.2 D, 0.8 D, 0.75 D, and 0.65 D, respectively. At the same times, the cylinder changes for patients receiving stromal hydration plus adhesive were 0.45 D, 0.35 D, 0.37 D, and 0.33 D, respectively. The reduced corneal change for patients treated with the adhesive was significantly less at all time points than for their counterparts.
No complications, including increased intraocular pressure and endophthalmitis, were observed.
The study was not designed to address how exactly the adhesive reduces astigmatism. That remains unresolved, Dr. Pamel noted. Not surprisingly, the researchers speculate that more efficient closure of an incision reduces the postoperative change in corneal shape.
The research team adds that, "there is a potential added significant benefit with the use of the novel adhesive: the potential reduction of the risk of endophthalmitis due to early wound ingress."
These benefits are not without danger. There is "clear evidence" that the surgery itself carries the risk for endophthalmitis. The absence of contamination in the present patient series may have reflected the small sample size, rather than the reality that becomes evident with many thousands of surgeries.
"I have my doubts about the data, until information from a masked, randomized, controlled study is available. For now, this approach is without merit," Herbert Kaufman, MD, professor of ophthalmology, pharmacology, and microbiology, emeritus, Louisiana State Medical School, New Orleans, told Medscape Medical News.
ReSure has yet to receive US Food and Drug Administration approval. Funding for the study was provided by Ocular Therapeutix. Dr. Pamel has disclosed relationships with Alcon/Wavelight, Kermaed, Ocular Theapeutix, and Seros Medical. Dr. Kaufman has disclosed no relevant financial relationships.
American Academy for Ophthalmology (AAO) 2011 Annual Meeting; Abstract PO008. Presented October 23, 2011.
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Cite this: Novel Tissue Adhesive Shows Promise in Cataract Surgery - Medscape - Nov 01, 2011.