23 Gauge and 20 Gauge Vitrectomy for Rhegmatogenous Retinal Detachments

Not Applicable

Completed

• Conditions: Retinal Detachment
• Interventions: Procedure: Retinal Detachment repair

• Registration Number: NCT01716507
• Lead Sponsor: Wills Eye

Brief Summary

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

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 Timeline

• Study Start: 2008-04
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-29
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-09
• Last Update Posted: 2016-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
23 gauge pars plana vitrectomy	Retinal Detachment repair	23 gauge pars plana vitrectomy for retinal detachment repair
20 gauge pars plana vitrectomy	Retinal Detachment repair	20 gauge pars plana vitrectomy for retinal detachment repair

Primary Outcome Measures

Name	Time	Method
Assess the initial retinal reattachment rates by comparing the percentages/amount.	1 Year

Secondary Outcome Measures

Name	Time	Method
Change in best-corrected visual acuity by comparing letters read.	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
Reattachment rates with 23 gauge and 20 gauge PPV by comparing the amount.	1 year	To determine the final retinal reattachment rates with 23-gauge and 20-gauge PPV if multiple surgeries are required.
Operating time for 23 gauge versus 20 gauge PPV (time measurement)	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.

Trial Locations

Locations (1)

Mid Atlantic Retina; 🇺🇸 Philadelphia, Pennsylvania, United States