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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2023-03-10

Brief Summary

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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

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

Conditions

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Macular Holes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Large MHs (diameter \> 550 μm)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

We never let the patient know the performed surgery

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jose Luis Rodriguez Loaiza

Medical Subdirector

Responsibility Role PRINCIPAL_INVESTIGATOR