Foldable Capsular Scleral Buckling Versus Vitrectomy in Medium-complex Rhegmatogenous Retinal Detachment Treatment

Официальное название

The Use of FCSB in Medium-complex RRD - a Safety and Efficacy Evaluation

Обзор

The objective of the study is to evaluate: 1. Safety and efficacy of a novel foldable capsular scleral buckle (FCSB) in scleral buckling for primary rhegmatogenous retinal detachment (RRD) of medium complexity. 2. Comparison between FCSB and pars plana vitrectomy in therapeutic effects and complications in the treatment of primary RRD of medium complexity.

Подробное описание

Pars plana vitrectomy (PPV) and scleral buckling (SB) are major choices in treating rhegmatogenous retinal detachment (RRD) of medium complexity. PPV is more prevailed since it improved internal search for breaks and elimination of vitreous traction. SB has unmatched advantages over PPV such as earlier rehabilitation, free from prolonged positioning, less complicated cataract or glaucoma. The novel foldable capsular scleral buckle (FCSB) can create a big bulge by pressing on the sclera and seal the break in bullous RRD without scleral drainage. In the study, differences of anatomic and functional results between PPV and FCSB in treating primary RRD of medium complexity are evaluated.

Вмешательства

• Процедура foldable capsular scleral buckling
  Using foldable capsular vitreous body as a novel scleral buckle material to treat the primary rhegmatogenous retinal detachment (RRD) of medium complexity
• Процедура vitrectomy
  Using vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity.

Первичные конечные точки

• anatomic success rate [Срок оценки: From enrollment to the end of treatment at 6 months]
• metamorphopsia [Срок оценки: From enrollment to the end of treatment at 6 months]
• Visual Results [Срок оценки: From enrollment to the end of treatment at 6 months]

Вторичные конечные точки (2)

• The number of surgeries that achieved successful final retinal reattachment [Срок оценки: From enrollment to the end of treatment at 6 months]
• Surgical Complications [Срок оценки: From enrollment to the end of treatment at 6 months]

Критерии участия

Критерии включения

One or more retinal holes which cannot be treated sufficiently with a single silicon sponge or silicone band (e.g. large holes, multiple holes, multiple holes of varying anterior-posterior localisation, massive traction)

Критерии исключения

• simple rhegmatogenous retinal detachment which can be treated with a single silicon sponge or silicone band (e.g. single holes, no traction, limit retinal detachment)
• Complicated RRD, including macular hole within the arcade, PVR C or D, severe cataract, severe vitreous hemorrhage, unclear macular hole,
• Combined with other eye diseases that affect vision prognosis.
• History of other eye surgeries including cataract surgery.
• Presence of systemic diseases that may affect postoperative observation and follow-up.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• EyeEntFudan — Шанхай

Идентификаторы

NCT: NCT06610786 · FCSB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗