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Foldable Capsular Scleral Buckling Versus Vitrectomy in Medium-complex Rhegmatogenous Retinal Detachment Treatment | Clinical Trials | Clareo Health

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

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

NCT06610786•Eye & ENT Hospital of Fudan University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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

•1. 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)
•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.

Locations (1)

EyeEntFudan

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

December 1, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2029

Last Updated

September 24, 2024

Enrollment

100

ESTIMATED participants

Conditions

Rhegmatogenous Retinal Detachment

Interventions

foldable capsular scleral buckling

PROCEDURE

vitrectomy

PROCEDURE

Dropless Pars Plana Vitrectomy Study

NCT05331664

Rhegmatogenous Retinal Detachment

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RECRUITINGPHASE2

Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial

NCT06541574

Proliferative VitreoretinopathyRhegmatogenous Retinal Detachment

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WITHDRAWN

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Dropless Pars Plana Vitrectomy Study

Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial

UNITY VCS Vitreoretinal Surgery

Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery

Prophylactic Intravitreal 5-Fluorouracil and Heparin to Prevent PVR in High-risk Patients With Retinal Detachment.

Early Prevention Strategies of Severe Proliferative Vitreoretinopathy Base on Precision Diagnosis of Single Cell Sequencingvitreoretinopathy