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

Comparison of Macular Hole Closure Rate in Patients With Poor Prognosis Clinical Features Treated With Amniotic Membrane Graft With and Without Limitorrhexis

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.

Study Overview

• Status: Recruiting
• Conditions: Macular Holes
• Intervention / Treatment: Procedure: Macular hole closure with amniotic membrane with/without internal limiting membrane peeling

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zita Chao Loyo, MD; Phone Number: +52 33994182; Email: investigacionretinaconval@gmail.com

Study Locations

• Mexico
  • Ciudad de Mexico, Mexico, 06800
    • Recruiting
    • INSTITUTO DE OFTALMOLOGIA CONDE DE VALENCIANA
    • Contact: Jose Luis Rodriguez Loaiza, MD; Phone Number: +52 5554123012; Email: jose.rodriguez@institutodeoftalmologia.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Amniotic membrane 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.	Procedure: Macular hole closure with amniotic membrane with/without internal limiting membrane peeling; Pars plana vitrectomy with/without internal limiting membrane peeling, amniotic membrane, and air tamponade
ACTIVE_COMPARATOR: Amniotic membrane with 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.	Procedure: Macular hole closure with amniotic membrane with/without internal limiting membrane peeling; Pars plana vitrectomy with/without internal limiting membrane peeling, amniotic membrane, and air tamponade

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of macular hole clousure measured with OCT	Closure of the macular hole by optical coherence tomography	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
• Investigators: Principal Investigator: Daniel Rios Esquer, MD, INSTITUTO DE OFTALMOLOGIA CONDE DE VALENCIANA; Principal Investigator: Ishtar A Astorga Carballo, MD, INSTITUTO DE OFTALMOLOGIA CONDE DE VALENCIANA; Principal Investigator: Jose L Rodriguez Loaiza, MD, INSTITUTO DE OFTALMOLOGIA CONDE DE VALENCIANA; Principal Investigator: Zita Chao Loyo, MD, INSTITUTO DE OFTALMOLOGIA CONDE DE VALENCIANA; Principal Investigator: Felipe Esparza Correa, MD, INSTITUTO DE OFTALMOLOGIA CONDE DE VALENCIANA

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 10, 2021
• Primary Completion (ANTICIPATED): December 10, 2022
• Study Completion (ANTICIPATED): March 10, 2023

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (ACTUAL): October 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: MAM CONDE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No