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

NCT06610786 | Not Yet Recruiting DMC

• 1 other identifier: FCSB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to evaluate:

1. 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. 2.Comparison between FCSB and pars plana vitrectomy in therapeutic effects and complications in the treatment of primary RRD of medium complexity.

Conditions

Rhegmatogenous Retinal Detachment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• The number of surgeries that achieved successful final retinal reattachment

  From enrollment to the end of treatment at 6 months

• Surgical Complications

  From enrollment to the end of treatment at 6 months

Study Arms (2)

FCSB

EXPERIMENTAL

Using foldable capsular scleral buckle surgery to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity

Procedure: foldable capsular scleral buckling

PPV

ACTIVE COMPARATOR

Using pars plana vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity

Procedure: vitrectomy

Interventions

foldable capsular scleral buckling PROCEDURE

Using foldable capsular vitreous body as a novel scleral buckle material to treat the primary rhegmatogenous retinal detachment (RRD) of medium complexity

FCSB

vitrectomy PROCEDURE

Using vitrectomy to treat primary rhegmatogenous retinal detachment (RRD) of medium complexity.

PPV

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

EyeEntFudan

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Interventions

Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 24, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)