Not Yet RecruitingNot Applicable

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

China100 participantsStarted 2024-12-01

Plain-language summary

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.

Who can participate

Age range18 Years – 60 Years

SexALL

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Exclusion criteria

✕. 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.

What they're measuring

anatomic success rate

Timeframe: From enrollment to the end of treatment at 6 months

metamorphopsia

Timeframe: From enrollment to the end of treatment at 6 months

Visual Results

Timeframe: From enrollment to the end of treatment at 6 months

Trial details

NCT IDNCT06610786

SponsorEye & ENT Hospital of Fudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

View on ClinicalTrials.gov More Rhegmatogenous Retinal Detachment trials