Large Macular Hole Closure Rate With Amniotic Membrane Graft With and Without Limitorrhexis

Not Applicable

• Conditions: Macular Holes
• Interventions: Procedure: Macular hole closure with amniotic membrane with/without internal limiting membrane peeling

• Registration Number: NCT05083650
• Lead Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

Brief Summary

Patients with idiopathic macular holes (MHs) postoperative closure rates for large MHs (diameter \> 550 μm) are disappointing and often require a second intervention, different techniques have been described with very variable success rates in different published studies, an efficient technique with good functional outcome has not been found.

Detailed Description

Interventional study in large macular holes (diameter \> 550 μm) using an amniotic membrane with and without internal limiting membrane peeling.

Study Timeline

• Study First Submitted: 2019-06-25
• Study Start: 2021-03-10
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-18
• Last Update Submitted: 2021-10-18
• Study First Posted: 2021-10-19
• Last Update Posted: 2021-10-19
• Primary Completion: 2022-12-10
• Study Completion: 2023-03-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Not myopic patients (<6 Dioptre or <26 mm)
• Large macular hole >550 μm
• > 6 months symptoms
• Signing informed consent

Exclusion Criteria

• Patients with other ocular disease (diabetic retinopathy, glaucoma, uveitis, ocular tumors, etc)
• Using systemic drugs that are toxic for the optic nerve or retina (chloroquine, hydroxychloroquine, tamoxifen, ethambutol, etc)
• Patients with ocular surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Amniotic membrane without internal limiting membrane peeling	Macular hole closure with amniotic membrane with/without internal limiting membrane peeling	The surgery performed will be phacoemulsification + vitrectomy using an amniotic membrane to plug the macular hole using air as tamponade.
Amniotic membrane with internal limiting membrane peeling	Macular hole closure with amniotic membrane with/without internal limiting membrane peeling	The surgery performed will be phacoemulsification + vitrectomy + internal limiting membrane peeling using an amniotic membrane to plug the macular hole using air as tamponade.

Primary Outcome Measures

Name	Time	Method
% of macular hole clousure measured with OCT	6 months	Closure of the macular hole by optical coherence tomography

Secondary Outcome Measures

Name	Time	Method
Superficial and deep retinal capillary plexus density with OCT-A	6 months	Presence of capillary plexus in macular hole area
Best-corrected visual acuity measured with Snellen Chart	6 months	Improvement of 2 lines in best-corrected visual acuity

Trial Locations

Locations (1)

Instituto de Oftalmologia Conde de Valenciana; 🇲🇽 Ciudad de Mexico, Mexico