The Use of Amniotic Membrane or Internal Limiting Membrane for Large or Refractory Macular Holes: A Prospective Study

NAActive, not recruitingINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

June 26, 2020

Primary Completion Date

September 30, 2023

Study Completion Date

December 31, 2025

Conditions
Macular Holes
Interventions
DEVICE

Pars plana Vitrectomy with internal limiting membrane peeling

"The pars plana 23-gauge (23G) vitrectomy technique will be performed with removal of the internal limiting membrane (ILM) (when adhered to the macula) and placement of either an amniotic membrane plug or an ILM flap in the macular hole. This will be followed by a fluid-air exchange and buffering gas infusion (12.5% C3F8).~The amniotic membrane plug will be prepared using a dermatological punch with a diameter of 1 to 2 mm, depending on the size of the macular hole as measured by OCT. It will be positioned inside the macular hole using 23G forceps, with its chorionic side facing the retinal pigmented epithelium (RPE).~The ILM flap will be created at the time of peeling-with an inverted flap in primary cases and a free flap in refractory cases. It will be positioned over the hole (inverted flap) or inside the macular hole (free flap) using 23G ILM forceps.~These techniques will be assisted by the use of an extra lighting sclerotomy."

Trial Locations (2)

18031060

Hospital Oftalmologico de Sorocaba/ Banco de Olhos de Sorocaba, Sorocaba

Sorocaba Eye's Hospital, Sorocaba

All Listed Sponsors
lead

Hospital Oftalmologico de Sorocaba

OTHER

NCT04904679 - The Use of Amniotic Membrane or Internal Limiting Membrane for Large or Refractory Macular Holes: A Prospective Study | Biotech Hunter | Biotech Hunter