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

ConditionRhegmatogenous Retinal Detachment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorEye & ENT Hospital of Fudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • foldable capsular scleral buckling

    Procedure/Surgery

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

  • vitrectomy

    Procedure/Surgery

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: FCSBExperimental treatment 1 intervention
Group B: PPVActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

anatomic success rate

The success rate of retinal reattachment

Time frame
From enrollment to the end of treatment at 6 months
2

metamorphopsia

metamorphopsia is measured by M chart

Time frame
From enrollment to the end of treatment at 6 months
3

Visual Results

Best-Corrected Visual Acuity, and is measured by Snellen Chart, EDTRS Chart and charts designed for people with low vision

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

Secondary outcomes

1

The number of surgeries that achieved successful final retinal reattachment

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

Time frame
From enrollment to the end of treatment at 6 months
2

Surgical Complications

Surgical Complications, included EOM dysfunction，Choroidal detachment，Clinical CME，Macular pucker，Postoperative IOP \>21 mmHg with medications

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eye & ENT Hospital of Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: