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

Macular Holes Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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 ).

Clinical Trial Description

This study will evaluate functional results through microperimetry of patients undergoing macular hole surgery ( for patients with macular holes ≥ 600 microns and in cases refractory to conventional surgical treatment) using amniotic membrane or internal limiting membrane as an adjunct in the closure process of the hole.

The current treatment considered the gold standard for the idiopathic macular holes consists of pars plana vitrectomy (PPV) with removal of the posterior hyaloid (when adhered) and the internal limiting membrane (ILM) with the help of a vital dye and subsequent placement of buffering gas (C3F8 or SF6) in non-expandable concentration. Approximately 44% of the large holes do not close after conventional surgery.

To increase the closure rate in these cases, new techniques have been proposed, such as the inverted ILM flap technique and the free ILM flap technique. Many studies demonstrate the effectiveness of these 2 techniques, but with no visual function improvement.

The amniotic membrane has been used in some cases as an adjunct in the macular holes closure and as a substrate for cell growth and improvement of visual acuity. Amniotic membranes are supposed to promote epithelialization and have anti-fibrotic, anti-inflammatory, anti-angiogenic and anti-microbial properties.

In the present study, the patients who meet the inclusion criteria will be randomized and undergo pars plana vitrectomy surgery with removal of the ILM and a fragment of the ILM itself or an amniotic membrane plug will be put in place approximately 1 -1.5 mm under the adjacent retina, inside the macular hole, with the chorionic face in contact with the retinal pigmented epithelium (RPE). After certifying that the plug is in the correct location, the gas fluid exchange will be performed, with a C3F8 buffering infusion of 12.5% and the patients will perform the face down position for 7 days.

The patients included in the study will undergo a complete eye examination, including corrected Visual Acuity measurement (BCVA), performing the Ocular Coherence Tomography ( OCT) using the Zeiss Cirrus 5000 equipment and microperimetry using the macular integrity assessment (MAIA) equipment in the pre-operative. Patients will undergo surgery after complementary exams and adequate pre-anesthetic evaluation.

Patients will be evaluated on the 1st and 7th postoperative days and at 1, 3, 6 and 12 months after surgery. The patient will undergo a complete eye examination and postoperative follow-up as described above, and during visits on the 7th day, and in the 1st, 3rd, 6th and 12th month of the postoperative period, OCT will be performed and the microperimetry will be performed in the 1st, 3rd, 6th and 12th postoperative month for evaluation and monitoring of anatomical and functional responses, respectively.

The use of the amniotic membrane, due to its anti-inflammatory, anti-fibrotic and substrate properties for cell growth is supposed do increase the rate of closure in the refractory and large holes, as well as promoting a better functional response by providing better reconstitution of the outer retinal layers.The amniotic membrane will be provided for this study by the SorocabaEye Bank (BOS), where it will be prepared and preserved. ;

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

• NCT number: NCT04904679
• Study type: Interventional
• Source: Hospital Oftalmologico de Sorocaba
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 26, 2020
• Completion date: December 31, 2023