Feasibility study for intraocular use of Seprafilm®

Abstract

Abstract: : Purpose: Failure to close retinal breaks is still the major cause of retinal re–detachment and proliferative vitreoretinopathy (PVR). Seprafilm^® (Genzyme Corporation) has been developed to help prevent adhesion after abdominal and pelvic surgery. This film sticks well to wet tissue. We explored the efficacy of this film in sealing retinal breaks. Methods:In Vitro Study: Retinal detachment with a hole was created in the bovine eye cup from which the vitreous gel had been removed. Seprafilm^® was then placed over the retinal hole. First, the strength of adhesion to the retina was measured by pulling this film. Next, permeability of the film was tested by applying diluted methylene blue to the surface of retina where Seprafilm^® was placed. Seprafilm^® was soaked in balanced salt solution (BSS), and was kept in the incubator at 37 ºC. The pH of the Seprafilm^® in the BSS was measured periodically as it melted. In Vivo Study: The Seprafilm^® was minced to the form of powder and mixed in BSS solution. 0.1cc of this solution was injected into the vitreous cavity of the right eye in rabbits. The BSS was injected into the vitreous cavity of other rabbits as control. Ophthalmological examinations were performed. ERG was recorded on both eyes simultaneously before injection and 42 days after injection, and then both eyes were enucleated for histological evaluation. Results: Seprafilm^® adhered well on the retina and was impermeable to methylene blue. Seprafilm^® remained solid in BSS for 30 days after which it dissolved completely. The pH was between pH 7.2 to 8.0. No inflammatory reaction was observed in the eye to which Seprafilm^® solution was injected. There was no significant difference in both amplitude and implicit time of a– and b–waves of the ERG in all stimulus intensity levels before and after injection and between study group and control group. No significant histological abnormality was detected in either group. Conclusions: The film in this study adhered well on the retina and showed no significant toxic effect to the eye. It warrants further study for possible means of patching the retinal break.

Keywords: retinal detachment • retinal adhesion • electroretinography: non–clinical