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

Macular Holes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05083650
• Other study ID #: MAM CONDE
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: March 10, 2023

Study information

• Verified date: October 2021
• Source: Instituto de Oftalmología Fundación Conde de Valenciana
• Contact: Zita Chao Loyo, MD
• Phone: +52 33994182
• Email: investigacionretinaconval[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: March 10, 2023
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

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

Locations

Country	Name	City	State
Mexico	Instituto de Oftalmologia Conde de Valenciana	Ciudad de Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Oftalmología Fundación Conde de Valenciana

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of macular hole clousure measured with OCT	Closure of the macular hole by optical coherence tomography	6 months
Secondary	Best-corrected visual acuity measured with Snellen Chart	Improvement of 2 lines in best-corrected visual acuity	6 months
Secondary	Superficial and deep retinal capillary plexus density with OCT-A	Presence of capillary plexus in macular hole area	6 months