NCT04904679

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Hospital Oftalmologico de Sorocaba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 ).

Detailed description

This study will evaluate functional outcomes through microperimetry in patients undergoing macular hole surgery. It will focus on patients with macular holes ≥600 microns, as well as those with holes refractory to conventional surgical treatment. The study will assess the use of amniotic membrane or internal limiting membrane (ILM) as adjuncts in the macular hole closure process. The gold-standard treatment for idiopathic macular holes is pars plana vitrectomy (PPV), which involves removal of the posterior hyaloid (when adhered) and the ILM using a vital dye, followed by placement of buffering gas (C3F8 or SF6) at a non-expandable concentration. However, approximately 44% of large macular holes remain unclosed after conventional surgery. To improve closure rates in such cases, new techniques have been introduced, including the inverted ILM flap technique and the free ILM flap technique. While studies demonstrate the effectiveness of these techniques, they show no significant improvement in visual function. The amniotic membrane (AM) has recently been explored as an adjunct for macular hole closure and as a substrate for cell growth and visual acuity improvement. Amniotic membranes are believed to promote epithelialization and possess anti-fibrotic, anti-inflammatory, anti-angiogenic, and antimicrobial properties. In this study, eligible patients will be randomized into two groups: * Group 1: Undergoing PPV with ILM removal, followed by placement of an amniotic membrane plug inside the macular hole, with its chorionic face in contact with the retinal pigment epithelium (RPE). * Group 2: Undergoing PPV with ILM removal, followed by placement of either an inverted ILM flap or a free ILM fragment for refractory cases, positioned over (inverted flap) or inside (free flap) the macular hole. Once the AM plug or ILM flap is confirmed in its correct location, a fluid-gas exchange will be performed with 12.5% C3F8 buffering gas, and patients will maintain a face-down position for 7 days postoperatively. Patients included in the study will undergo: * Preoperative assessment, including best-corrected visual acuity (BCVA) measurement, optical coherence tomography (OCT) using the Zeiss Cirrus 5000, and microperimetry using the Macular Integrity Assessment (MAIA) device. * Postoperative evaluations at day 1 and day 7, followed by assessments at 1, 3, 6, and 12 months. During these visits:- A complete ophthalmic examination will be performed. * OCT imaging will be conducted at day 7, month 1, month 3, month 6, and month 12. * Microperimetry will be conducted at months 1, 3, 6, and 12 to evaluate anatomical and functional responses. The use of the amniotic membrane, given its anti-inflammatory, anti-fibrotic, and cell growth-supporting properties, is expected to increase closure rates in refractory and large macular holes and contribute to better functional outcomes by supporting outer retinal layer regeneration. The Sorocaba Eye Bank (BOS) will provide, prepare, and preserve the amniotic membrane used in this study.

Conditions

• Macular Holes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-26
• Primary completion: 2023-09-30
• Completion: 2025-12-31
• First posted: 2021-05-27
• Last updated: 2025-05-06

Locations

2 sites across 1 country: Brazil