Menu
Not yet recruiting NCT06610786

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

No phase Interventional Rhegmatogenous Retinal Detachment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: foldable capsular scleral buckling, vitrectomy.
Who it may be relevant to
Registry conditions: Rhegmatogenous Retinal Detachment. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • anatomic success rate [Time frame: From enrollment to the end of treatment at 6 months]
  • metamorphopsia [Time frame: From enrollment to the end of treatment at 6 months]
  • Visual Results [Time frame: From enrollment to the end of treatment at 6 months]
Secondary outcome measures (2)
  • The number of surgeries that achieved successful final retinal reattachment [Time frame: From enrollment to the end of treatment at 6 months]
  • Surgical Complications [Time frame: From enrollment to the end of treatment at 6 months]

Eligibility criteria

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • EyeEntFudan — Shanghai

Identifiers

NCT: NCT06610786 · FCSB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗