Vitrectomy Clinical Trials

Clinical trials related to Vitrectomy Procedure

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

Status: Recruiting

Location: See location...

Intervention Type: Biological, Procedure, Other

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• Adults aged ≥18 years.

• Full-thickness macular hole (FTMH) eligible for pars plana vitrectomy (PPV).

• Symptom duration ≤12 months.

• Clear ocular media sufficient for high-quality OCT imaging.

• No prior pars plana vitrectomy in the study eye.

• No severe foveal atrophy on OCT.

• Able and willing to comply with postoperative positioning and follow-up visits.

• Written informed consent provided.

Locations

Other Locations

Kazakhstan

Kazakh Eye Research Institute

RECRUITING

Almaty

Contact Information

Primary

Sanzhar Sambet, MD

sanzhrs@gmail.com

+77758719834

Backup

Kairat Ruslanuly, MD

ruslanuly.kairat@gmail.com

+77019008387

Time Frame

Start Date: 2026-05-25

Estimated Completion Date: 2028-05-27

Participants

Target number of participants: 120

Treatments

Active_comparator: PPV + PVD Induction Without ILM Peel/Flap

Pars plana vitrectomy (PPV) with induction of posterior vitreous detachment (PVD) performed without internal limiting membrane (ILM) peeling and without an ILM flap.

Active_comparator: PPV + ERM peel + circular ILM peel (classic)

Pars plana vitrectomy (PPV) with epiretinal membrane (ERM) peeling (if present) followed by standard circular internal limiting membrane (ILM) peeling around the fovea (classic technique).

Active_comparator: PPV + 360° Inverted ILM Flap

Pars plana vitrectomy (PPV) with creation of a circumferential (360°) internal limiting membrane (ILM) flap that is inverted to cover the macular hole, according to the study protocol.

Active_comparator: PPV + Superior Hinged ILM Flap

Pars plana vitrectomy (PPV) with creation of a superior hinged internal limiting membrane (ILM) flap left attached at the superior edge and inverted to cover the macular hole, according to the study protocol.

Active_comparator: PPV + Temporal Hinged ILM Flap

Pars plana vitrectomy (PPV) with creation of a temporal hinged internal limiting membrane (ILM) flap, left attached at the temporal edge, and inverted to cover the macular hole, according to the study protocol.

Active_comparator: PPV + Multiflap ILM Flap (Cabbage Leaf/Star)

Pars plana vitrectomy (PPV) with creation of multiple small internal limiting membrane (ILM) flaps (multiflap cabbage leaf/star technique) positioned to cover the macular hole, according to the study protocol.

Active_comparator: PPV + ILM removal + inverted flap + PRP

Pars plana vitrectomy (PPV) with internal limiting membrane (ILM) removal and an inverted ILM flap technique. Autologous platelet-rich plasma (PRP) is applied to the macular hole area as an adjunct, according to the study protocol.

Active_comparator: PPV + ILM removal + PRP

Pars plana vitrectomy (PPV) with standard internal limiting membrane (ILM) peeling (no ILM flap technique). Autologous platelet-rich plasma (PRP) is applied to the macular hole area as an adjunct, according to the study protocol.

Active_comparator: PPV + ILM Peeling + Human Amniotic Membrane (hAM) Graft

Pars plana vitrectomy (PPV) with standard internal limiting membrane (ILM) peeling followed by placement of a human amniotic membrane (hAM) graft for full-thickness macular hole repair, according to the study protocol.

Active_comparator: PPV + Macular Edge Hydrodissection

Pars plana vitrectomy (PPV) with controlled hydrodissection (hydromobilization) of the macular hole edges using balanced salt solution to gently separate and mobilize the retinal margins before macular hole closure, according to the study protocol.

Related Therapeutic Areas

Vitrectomy

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