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

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana (Other)

Overall Status

Recruiting

CT.gov ID

NCT05083650

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Holes	Procedure: Macular hole closure with amniotic membrane with/without internal limiting membrane peeling	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Large MHs (diameter > 550 μm)Large MHs (diameter > 550 μm)

Masking:

Double (Participant, Care Provider)

Masking Description:

We never let the patient know the performed surgery

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 10, 2021

Anticipated Primary Completion Date :

Dec 10, 2022

Anticipated Study Completion Date :

Mar 10, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

% of macular hole clousure measured with OCT [6 months]
Closure of the macular hole by optical coherence tomography

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto de Oftalmologia Conde de Valenciana	Ciudad de Mexico		Mexico	06800

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jose Luis Rodriguez Loaiza, Medical Subdirector, Instituto de Oftalmología Fundación Conde de Valenciana

ClinicalTrials.gov Identifier:

NCT05083650

Other Study ID Numbers:

MAM CONDE

First Posted:

Oct 19, 2021

Last Update Posted:

Oct 19, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinal Perforations

Study Results

No Results Posted as of Oct 19, 2021