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Full-Thickness Macular Hole Surgery: A Comparison of Ten Techniques

NCT07606404 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-26

No results posted yet for this study

Summary

This study compares ten modern vitreoretinal surgical techniques for full-thickness macular hole repair. Participants will be randomly assigned to one of the surgical approaches during pars plana vitrectomy, using stratified randomization based on macular hole size to ensure balanced groups. The main goal is to determine which technique provides the highest anatomical closure rate on optical coherence tomography (OCT) and the best visual outcomes. Follow-up visits are scheduled at Day 7, Month 1, and Year 1 after surgery to assess OCT findings, visual acuity, safety outcomes, and the need for reoperation.

Conditions

  • Macular Holes

Interventions

PROCEDURE

Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery

Pars plana vitrectomy (PPV) for full-thickness macular hole repair performed according to the randomized assigned technique (e.g., ERM peel, ILM peeling, ILM flap configurations, or macular edge hydrodissection), as specified in the protocol.

BIOLOGICAL

Autologous Platelet-Rich Plasma (PRP)

Autologous platelet-rich plasma (PRP) applied intraoperatively to the macular hole area as an adjunct to surgery, according to the study protocol.

OTHER

Human Amniotic Membrane (hAM) Graft

Human amniotic membrane (hAM) graft placed intraoperatively for macular hole repair, according to the study protocol.

Sponsors & Collaborators

  • Kazakh Eye Research Institute

    lead NETWORK

Principal Investigators

  • Sanzhar Sambet Sambet, MD · Kazakh Eye Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-25
Primary Completion
2027-05-27
Completion
2028-05-27

Countries

  • Kazakhstan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07606404 on ClinicalTrials.gov