23 Gauge and 20 Gauge Vitrectomy for Rhegmatogenous Retinal Detachments

December 9, 2016 updated by: Wills Eye

A Prospective, Randomized Study Comparing 23-gauge and 20-gauge Pars Plana Vitrectomy for Repair of Pseudophakic Rhegmatogenous Retinal Detachments

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 20 gauge pars plana vitrectomy
20 gauge pars plana vitrectomy for retinal detachment repair
Procedure: Retinal Detachment repair
Comparing 23 gauge vs 20 gauge pars plana vitrectomy.
Other: 23 gauge pars plana vitrectomy
23 gauge pars plana vitrectomy for retinal detachment repair
Procedure: Retinal Detachment repair
Comparing 23 gauge vs 20 gauge pars plana vitrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the initial retinal reattachment rates by comparing the percentages/amount.
Time Frame: 1 Year
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in best-corrected visual acuity by comparing letters read.
Time Frame: 6 months
To determine the change in best-corrected visual acuity (BCVA) at the pre-operative visit compared to the 6 month post-operative visit
6 months
Reattachment rates with 23 gauge and 20 gauge PPV by comparing the amount.
Time Frame: 1 year
To determine the final retinal reattachment rates with 23-gauge and 20-gauge PPV if multiple surgeries are required.
1 year
Operating time for 23 gauge versus 20 gauge PPV (time measurement)
Time Frame: 1 day- Day of surgery
This will be done to determine operating times for 23-gauge versus 20-gauge PPV for primary repair of PRD.
1 day- Day of surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare rates of intraoperative and postoperative complications by comparing the amount and severity of these complications.
Time Frame: 1 year
To describe and compare rates of intraoperative and postoperative complications with 23-gauge versus 20-gauge PPV for primary repair of PRD, including but not limited to post-operative hypotony, choroidal detachment, proliferative vitreoretinopathy, and endophthalmitis.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wills Eye

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

October 25, 2012

First Submitted That Met QC Criteria

October 25, 2012

First Posted (Estimate)

October 29, 2012

Study Record Updates

Last Update Posted (Estimate)

December 12, 2016

Last Update Submitted That Met QC Criteria

December 9, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23VS20RD
  • IRB08858 (Other Identifier: WillsEyeIRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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