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ACTIVE NOT RECRUITING
NCT04904679
NA

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

Sponsor: Hospital Oftalmologico de Sorocaba

View on ClinicalTrials.gov

Summary

Prospective, randomized, unmasked interventional study. To evaluate anatomical and functional results through microperimetry in cases of refractory or large macular holes (MH), using amniotic membrane (AM) or internal limiting membrane ( ILM ).

Official title: The Use of Amniotic Membrane or Inverted Internal Limiting Membrane Flap for Large or Refractory Macular Holes: a Prospective, Comparative Study Using Microperimetry

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2020-06-26

Completion Date

2025-12-31

Last Updated

2025-05-06

Healthy Volunteers

No

Conditions

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.

Locations (2)

Hospital Oftalmologico de Sorocaba/ Banco de Olhos de Sorocaba

Sorocaba, São Paulo, Brazil

Sorocaba Eye's Hospital

Sorocaba, São Paulo, Brazil