Foldable Capsular Scleral Buckling Versus Vitrectomy in Medium-complex Rhegmatogenous Retinal Detachment Treatment
- Conditions
- Rhegmatogenous Retinal Detachment
- Interventions
- Procedure: foldable capsular scleral bucklingProcedure: vitrectomy
- Registration Number
- NCT06610786
- Lead Sponsor
- Eye & ENT Hospital of Fudan University
- 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 complexity.
2. Comparison between FCSB and pars plana vitrectomy in therapeutic effects and complications in the treatment of primary RRD of medium complexity.
- 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 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FCSB foldable capsular scleral buckling Using foldable capsular scleral buckle surgery to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity PPV vitrectomy Using pars plana vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity
- Primary Outcome Measures
Name Time Method anatomic success rate From enrollment to the end of treatment at 6 months The success rate of retinal reattachment
metamorphopsia From enrollment to the end of treatment at 6 months metamorphopsia is measured by M chart
Visual Results From enrollment to the end of treatment at 6 months Best-Corrected Visual Acuity, and is measured by Snellen Chart, EDTRS Chart and charts designed for people with low vision
- Secondary Outcome Measures
Name Time Method The number of surgeries that achieved successful final retinal reattachment From enrollment to the end of treatment at 6 months The number of surgeries the patient undergoes to achieve final retinal reattachment
Surgical Complications From enrollment to the end of treatment at 6 months Surgical Complications, included EOM dysfunction，Choroidal detachment，Clinical CME，Macular pucker，Postoperative IOP \>21 mmHg with medications
Trial Locations
- Locations (1)
EyeEntFudan
🇨🇳Shanghai, Shanghai, China