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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rhegmatogenous Retinal Detachment
• Intervention / Treatment: Procedure: foldable capsular scleral buckling; Procedure: vitrectomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • EyeEntFudan
      • Contact: Zhongcui Sun, PhD; Phone Number: +8621-64377134-2501; Email: zhongcui.sun@aliyun.com
      • Contact: ruiping Gu, phD; Phone Number: +8621-64377134-2501; Email: pingruigu@126.com
      • Contact: Zhongcui Sun, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FCSB; Using foldable capsular scleral buckle surgery to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity	Procedure: 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
Active Comparator: PPV; Using pars plana vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity	Procedure: vitrectomy; Using vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anatomic success rate	The success rate of retinal reattachment	From enrollment to the end of treatment at 6 months
metamorphopsia	metamorphopsia is measured by M chart	From enrollment to the end of treatment at 6 months
Visual Results	Best-Corrected Visual Acuity, and is measured by Snellen Chart, EDTRS Chart and charts designed for people with low vision	From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of surgeries that achieved successful final retinal reattachment	The number of surgeries the patient undergoes to achieve final retinal reattachment	From enrollment to the end of treatment at 6 months
Surgical Complications	Surgical Complications, included EOM dysfunction，Choroidal detachment，Clinical CME，Macular pucker，Postoperative IOP >21 mmHg with medications	From enrollment to the end of treatment at 6 months

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Detachment
• Other Study ID Numbers: FCSB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No