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

Primary Purpose

Macular Holes

Status

Unknown status

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Macular hole closure with amniotic membrane with/without internal limiting membrane peeling

About this trial

This is an interventional treatment trial for Macular Holes

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Instituto de Oftalmologia Conde de ValencianaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Amniotic membrane without internal limiting membrane peeling

Amniotic membrane with internal limiting membrane peeling

Arm Description

The surgery performed will be phacoemulsification + vitrectomy using an amniotic membrane to plug the macular hole using air as tamponade.

The surgery performed will be phacoemulsification + vitrectomy + internal limiting membrane peeling using an amniotic membrane to plug the macular hole using air as tamponade.

Outcomes

Primary Outcome Measures

% of macular hole clousure measured with OCT

Closure of the macular hole by optical coherence tomography

Secondary Outcome Measures

Best-corrected visual acuity measured with Snellen Chart

Improvement of 2 lines in best-corrected visual acuity

Superficial and deep retinal capillary plexus density with OCT-A

Presence of capillary plexus in macular hole area

Full Information

NCT ID

NCT05083650

First Posted

June 25, 2019

Last Updated

October 18, 2021

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

1. Study Identification

Unique Protocol Identification Number

NCT05083650

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 10, 2021 (Actual)

Primary Completion Date

December 10, 2022 (Anticipated)

Study Completion Date

March 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Holes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

Large MHs (diameter > 550 μm)

Masking

ParticipantCare Provider

Masking Description

We never let the patient know the performed surgery

Allocation

Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Amniotic membrane without internal limiting membrane peeling

Arm Type

Experimental

Arm Description

The surgery performed will be phacoemulsification + vitrectomy using an amniotic membrane to plug the macular hole using air as tamponade.

Arm Title

Amniotic membrane with internal limiting membrane peeling

Arm Type

Active Comparator

Arm Description

The surgery performed will be phacoemulsification + vitrectomy + internal limiting membrane peeling using an amniotic membrane to plug the macular hole using air as tamponade.

Intervention Type

Procedure

Intervention Name(s)

Macular hole closure with amniotic membrane with/without internal limiting membrane peeling

Intervention Description

Pars plana vitrectomy with/without internal limiting membrane peeling, amniotic membrane, and air tamponade

Primary Outcome Measure Information:

Title

% of macular hole clousure measured with OCT

Description

Closure of the macular hole by optical coherence tomography

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Best-corrected visual acuity measured with Snellen Chart

Description

Improvement of 2 lines in best-corrected visual acuity

Time Frame

6 months

Title

Superficial and deep retinal capillary plexus density with OCT-A

Description

Presence of capillary plexus in macular hole area

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zita Chao Loyo, MD

Phone

+52 33994182

investigacionretinaconval@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Rios Esquer, MD

Organizational Affiliation