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NCT Number: NCT06610786

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Vitrectomy

Procedure

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

Primary outcomes

  1. anatomic success rate

    Time frame: From enrollment to the end of treatment at 6 months

    The success rate of retinal reattachment

  2. metamorphopsia

    Time frame: From enrollment to the end of treatment at 6 months

    metamorphopsia is measured by M chart

  3. Visual Results

    Time frame: 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 outcomes

  1. The number of surgeries that achieved successful final retinal reattachment

    Time frame: From enrollment to the end of treatment at 6 months

    The number of surgeries the patient undergoes to achieve final retinal reattachment

  2. Surgical Complications

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

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

Acronym: FCSB

Important dates

Study start
2024
Primary completion
2025
Study completion
2029
First posted
Sep 24, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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