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23 Gauge and 20 Gauge Vitrectomy for Rhegmatogenous Retinal Detachments

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01716507
Enrollment
46
Registered
2012-10-29
Start date
2008-04-30
Completion date
2011-07-31
Last updated
2016-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Detachment

Keywords

RRD, Rhegmatogenous, Retinal, Detachment, PPV, Pars Plana Vitrectomy, Gauge

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.

Interventions

PROCEDURERetinal Detachment repair

Comparing 23 gauge vs 20 gauge pars plana vitrectomy.

Sponsors

Wills Eye
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Assess the initial retinal reattachment rates by comparing the percentages/amount.1 Year

Secondary

MeasureTime frameDescription
Change in best-corrected visual acuity by comparing letters read.6 monthsTo 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 yearTo 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 surgeryThis will be done to determine operating times for 23-gauge versus 20-gauge PPV for primary repair of PRD.

Other

MeasureTime frameDescription
Compare rates of intraoperative and postoperative complications by comparing the amount and severity of these complications.1 yearTo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026