Status:
NOT_YET_RECRUITING
Foldable Capsular Scleral Buckling Versus Vitrectomy in Medium-complex Rhegmatogenous Retinal Detachment Treatment
Lead Sponsor:
Eye & ENT Hospital of Fudan University
Conditions:
Rhegmatogenous Retinal Detachment
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 ...
Detailed Description
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 searc...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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)
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06610786
Start Date
December 1 2024
End Date
December 1 2029
Last Update
September 24 2024
Active Locations (1)
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1
EyeEntFudan
Shanghai, Shanghai Municipality, China, 200031