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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Биопрепарат 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.
• Другое Human Amniotic Membrane (hAM) Graft
  Human amniotic membrane (hAM) graft placed intraoperatively for macular hole repair, according to the study protocol.

Первичные конечные точки

• Macular Hole Closure at 7 days [Срок оценки: 7 day]
• Macular Hole Closure at 1month [Срок оценки: 1 month]
• Macular Hole Closure at 1 Year [Срок оценки: 1 year]

Вторичные конечные точки (3)

• BCVA at Day 7 [Срок оценки: 7 days]
• BCVA at 1 Month [Срок оценки: 1 month]
• BCVA at 1 Year [Срок оценки: 1 year]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Казахстан · 1 центр

• Kazakh Eye Research Institute — Almaty

Идентификаторы

NCT: NCT07606404 · IRB-538-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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