23 Gauge and 20 Gauge Vitrectomy for Rhegmatogenous Retinal Detachments

Retinal Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716507
• Other study ID #: 23VS20RD
• Secondary ID: IRB08858
• Status: Completed
• Phase: N/A
• First received: October 25, 2012
• Last updated: December 9, 2016
• Start date: April 2008
• Est. completion date: July 2011

Study information

• Verified date: December 2016
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment

Intervention

Procedure:
• Retinal Detachment repair
Comparing 23 gauge vs 20 gauge pars plana vitrectomy.

Locations

Country	Name	City	State
United States	Mid Atlantic Retina	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Wills Eye

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare rates of intraoperative and postoperative complications by comparing the amount and severity of these complications.	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	Yes
Primary	Assess the initial retinal reattachment rates by comparing the percentages/amount.		1 Year	Yes
Secondary	Change in best-corrected visual acuity by comparing letters read.	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	No
Secondary	Reattachment rates with 23 gauge and 20 gauge PPV by comparing the amount.	To determine the final retinal reattachment rates with 23-gauge and 20-gauge PPV if multiple surgeries are required.	1 year	No
Secondary	Operating time for 23 gauge versus 20 gauge PPV (time measurement)	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	No