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

NCT ID: NCT06610786

Last Updated: 2024-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2029-12-01

Brief Summary

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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

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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.

Conditions

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Rhegmatogenous Retinal Detachment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FCSB

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

Group Type EXPERIMENTAL

foldable capsular scleral buckling

Intervention Type PROCEDURE

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

PPV

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

Group Type ACTIVE_COMPARATOR

vitrectomy

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

vitrectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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EyeEntFudan

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Facility Contacts

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Zhongcui Sun, PhD

Role: primary

+8621-64377134-2501

ruiping Gu, phD

Role: backup

+8621-64377134-2501

Zhongcui Sun, PhD

Role: backup

Other Identifiers

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FCSB

Identifier Type: -

Identifier Source: org_study_id

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