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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05083650

Enrollment

Registered

2021-10-19

Start date

2021-03-10

Completion date

2023-03-10

Last updated

2021-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Holes

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.

Interventions

PROCEDUREMacular 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

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Masking description

We never let the patient know the performed surgery

Intervention model description

Large MHs (diameter \> 550 μm)

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
% of macular hole clousure measured with OCT	6 months	Closure of the macular hole by optical coherence tomography

Secondary

Measure	Time frame	Description
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

Countries

Mexico

Contacts

Primary ContactZita Chao Loyo, MD

investigacionretinaconval@gmail.com+52 33994182

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026