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

Instituto de Oftalmología Fundación Conde de Valenciana

Status: Unknown

Conditions: Macular Holes

Treatments: Procedure: Macular hole closure with amniotic membrane with/without internal limiting membrane peeling

Study type: Interventional

Funder types: Other

Identifiers

NCT05083650

MAM CONDE

Details and patient eligibility

About

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.

Full description

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

Enrollment: 16 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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16 participants in 2 patient groups

Amniotic membrane without internal limiting membrane peeling

Experimental group

Description:

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

Treatment:

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

Amniotic membrane with internal limiting membrane peeling

Active Comparator group

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.

Treatment:

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