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RECRUITING
NCT07606404
NA

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

Sponsor: Kazakh Eye Research Institute

View on ClinicalTrials.gov

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.

Official title: Vitreoretinal Surgery for Full-Thickness Macular Hole: A Comparative Study of Ten Techniques

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-05-25

Completion Date

2028-05-27

Last Updated

2026-06-02

Healthy Volunteers

No

Conditions

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.

Locations (1)

Kazakh Eye Research Institute

Almaty, Almaty, Kazakhstan