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23 Gauge and 20 Gauge Vitrectomy for Rhegmatogenous Retinal Detachments

NCT ID: NCT01716507

Last Updated: 2016-12-12

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

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-07-31

Brief Summary

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This study is a comparison (23 gauge vs 20 gauge instrumentation) of surgical instrumentation for retinal detachment repair.

Detailed Description

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The majority of studies on PPV for PRD up to this time have used 20-gauge instrumentation. Currently, both 23-gauge and 20-gauge instrumentation are commercially available for PPV. No studies have reported the efficacy of 23-gauge PPV compared to 20-gauge PPV for primary pseudophakic RRD. As a result, many retinal surgeons choose the modality based on personal preference.

Conditions

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Retinal Detachment

Keywords

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RRD Rhegmatogenous Retinal Detachment PPV Pars Plana Vitrectomy Gauge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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20 gauge pars plana vitrectomy

20 gauge pars plana vitrectomy for retinal detachment repair

Group Type OTHER

Retinal Detachment repair

Intervention Type PROCEDURE

Comparing 23 gauge vs 20 gauge pars plana vitrectomy.

23 gauge pars plana vitrectomy

23 gauge pars plana vitrectomy for retinal detachment repair

Group Type OTHER

Retinal Detachment repair

Intervention Type PROCEDURE

Comparing 23 gauge vs 20 gauge pars plana vitrectomy.

Interventions

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Retinal Detachment repair

Comparing 23 gauge vs 20 gauge pars plana vitrectomy.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Ability to provide written consent and comply with study assessments for the full duration of the study.
* Presence of retinal detachment with history of cataract surgery.
* Vision of hand motion or better.

Exclusion Criteria

* Presence of a very large tear or type of retinal detachment usually a result of trauma.
* Prior eye surgery except for cataract surgery.
* Presence of significant scar tissue.
* Presence of retinal detachment due to hole in the macula.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wills Eye

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye

Locations

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Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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IRB08858

Identifier Type: OTHER

Identifier Source: secondary_id

23VS20RD

Identifier Type: -

Identifier Source: org_study_id