Acellular Descemet’s Membrane as a surgical adjunct for macular hole closure – a pilot study

Abstract

Purpose : To investigate the safety and efficacy of acellular human Descemet’s membrane (aDM) as a surgical adjunct for macular hole closure in a non-human primate (NHP) model of macular hole (MH) formation.

Methods : One adult rhesus monkey underwent sequential pars plana vitrectomies in both eyes with experimental MH formation and implantation of aDM. Electron-beam (e-beam) irradiated DM was provided by VisionGift (SightGraft^TM, Portland, OR), and the absence of cells was confirmed with histopathology. After core vitrectomy and elevation of the posterior hyaloid, MH was created via injection of balanced salt solution (BSS) into the subfoveal space with a 27G/38-gauge subretinal infusion cannula, which was connected to MicroDose Injector system. The MicroDose injector was connected to the vitrectomy machine to allow actuation of the syringe stopper via surgeon foot pedal control. After a MH had been opened in the fovea by the water pressure from the BSS injection, a soft tip was used to enlarge the MH to approximately 1.5x of the optic disc diameter. A partial fluid air exchange was completed and the sclerostomies were sutured. MH was confirmed 1 week post-op by OCT (Spectralis, OCT2, Heidelberg Engineering, GmbH) and subsequent vitrectomy with implantation of aDM over the area of the MH was performed. For the surgical implantation, aDM was stained with brilliant blue dye and perfluoron was injected in the posterior pole to stabilize and unroll the aDM. A direct PFO-silicone oil exchange was performed. Eyes were imaged 1-week later to assess closure of the macular hole.

Results : Both eyes that had surgically induced macular holes exhibited closure of the MH at week-1 under silicone oil tamponade. aDM was well tolerated within the vitreous cavity without any safety alerts.

Conclusions : Acellular DM was well tolerated and aided in successful macular hole closure in both eyes without any apparent retinal toxicity. Further clinical studies are underway to demonstrate any potential advantages over conventional surgical techniques for macular hole closure.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.

 

(A) Intraoperative photo demonstrating placement of acellular Descemet’s membrane stained with brilliant blue dye over the macular hole. aDM is stabilized under perfluoron. (B) Pre-operative SD-OCT confirming formation of macular hole and (C) closure 1 week after implantation and silicone oil tamponade.