An interventional study of Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery and Autologous Platelet-Rich Plasma (PRP) in Macular Holes, sponsored by Kazakh Eye Research Institute. Recruiting at 1 site in Kazakhstan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Kazakh Eye Research Institute · Not applicable, Interventional, and Treatment
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.
Full-thickness macular hole is a vision-threatening condition that is commonly treated with pars plana vitrectomy (PPV) and internal limiting membrane (ILM) peeling. While standard approaches achieve high closure rates in many cases, outcomes may vary depending on macular hole size and OCT morphology, and advanced surgical strategies (e.g., different ILM flap configurations, adjunctive biologic augmentation, hydrodissection, or grafting techniques) are increasingly used in clinical practice.
This single-center, randomized, parallel-group interventional study will compare ten PPV-based surgical techniques for full-thickness macular hole repair. Eligible participants will include adults with full-thickness macular hole across a broad range of minimum linear diameter (MLD), including MLD \<250 µm. After eligibility confirmation and informed consent, participants will be randomized to one of the ten procedure groups. Randomization will be stratified by macular hole size into five predefined MLD strata to ensure balanced distribution of hole sizes across all intervention groups. Postoperative care and follow-up procedures will be standardized across groups according to the study protocol.
Follow-up visits are scheduled at Day 7, Month 1, and Year 1 after surgery and will include clinical examinations and OCT imaging. The primary endpoint is anatomical macular hole closure on OCT at the prespecified primary time point. Secondary endpoints include best-corrected visual acuity (BCVA), OCT-based morphologic recovery parameters, intraoperative and postoperative complication rates, reoperation rates, and adverse event information through Year 1. The study aims to generate evidence to guide selection of surgical technique based on macular hole morphometric and clinical characteristics while maintaining patient safety.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 94 interventional studies indexed under Retinal Perforations.
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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 provided.
Exclusion Criteria:
A. Etiology-Related / Secondary Macular Holes:
Traumatic macular hole.
High myopia with posterior staphyloma (axial length >28 mm and/or spherical equivalent ≤-8.0 D).
Diabetic tractional retinal detachment (TRD) or significant tractional maculopathy.
Retinal vascular occlusion-related macular hole.
Uveitis-related macular hole.
Advanced age-related macular degeneration (AMD) with foveal atrophy.
B. Prior Interventions:
Any prior pars plana vitrectomy in the study eye.
C. Ocular Conditions That May Affect Outcomes or Safety:
Active or recent ocular infection or inflammation (e.g., uveitis, endophthalmitis, keratitis).
Uncontrolled glaucoma (intraocular pressure >28 mmHg despite treatment).
Media opacity precluding adequate OCT (e.g., dense cataract or corneal opacity).
Geographic atrophy involving the fovea.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pars plana vitrectomy (PPV) with induction of posterior vitreous detachment (PVD) performed without internal limiting membrane (ILM) peeling and without an ILM flap.
Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery
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).
Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery
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.
Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery
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.
Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery
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.
Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery
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.
Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery
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.
Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery · Biological: Autologous Platelet-Rich Plasma (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.
Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery · Biological: Autologous Platelet-Rich Plasma (PRP)
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.
Procedure: Pars Plana Vitrectomy (PPV)-Based Macular Hole Surgery · Other: Human Amniotic Membrane (hAM) Graft
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.
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.
Autologous platelet-rich plasma (PRP) applied intraoperatively to the macular hole area as an adjunct to surgery, according to the study protocol.
Human amniotic membrane (hAM) graft placed intraoperatively for macular hole repair, according to the study protocol.
Macular Hole Closure at 7 days
Proportion of participants with OCT-confirmed anatomical macular hole closure.
Time frame: 7 day
Macular Hole Closure at 1month
Proportion of participants with OCT-confirmed anatomical macular hole closure.
Time frame: 1 month
Macular Hole Closure at 1 Year
Proportion of participants with OCT-confirmed anatomical macular hole closure.
Time frame: 1 year
BCVA at Day 7
Best-corrected visual acuity (BCVA) measured at Day 7 after surgery and recorded in logMAR units.
Time frame: 7 days
BCVA at 1 Month
Best-corrected visual acuity (BCVA) measured at 1 month after surgery and recorded in logMAR units.
Time frame: 1 month
BCVA at 1 Year
Best-corrected visual acuity (BCVA) measured at 1 year after surgery and recorded in logMAR units.
Time frame: 1 year
Plan to share: No — This study does not plan to share individual participant data (IPD) publicly. De-identified aggregated results may be shared in publications and presentations.
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Studies of the drug tested here: Platelet rich plasma
Kazakh Eye Research Institute