Foldable Capsular Scleral Buckling Versus Vitrectomy in Medium-complex Rhegmatogenous Retinal Detachment Treatment
NCT ID: NCT06610786
Last Updated: 2024-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2024-12-01
2029-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FCSB
Using foldable capsular scleral buckle surgery to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity
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
PPV
Using pars plana vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity
vitrectomy
Using vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity.
Interventions
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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
vitrectomy
Using vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Complicated RRD, including macular hole within the arcade, PVR C or D, severe cataract, severe vitreous hemorrhage, unclear macular hole,
3. Combined with other eye diseases that affect vision prognosis.
4. History of other eye surgeries including cataract surgery.
5. Presence of systemic diseases that may affect postoperative observation and follow-up.
18 Years
60 Years
ALL
No
Sponsors
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Eye & ENT Hospital of Fudan University
OTHER
Responsible Party
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Locations
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EyeEntFudan
Shanghai, Shanghai Municipality, China
Countries
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Facility Contacts
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Zhongcui Sun, PhD
Role: backup
Other Identifiers
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FCSB
Identifier Type: -
Identifier Source: org_study_id
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