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OpenTrials
Completed

NCT Number: NCT01716507

23 Gauge and 20 Gauge Vitrectomy for Rhegmatogenous Retinal Detachments

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

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Key information

Conditions

Retinal Detachment Eye Diseases Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retinal Detachment repair

Procedure

Comparing 23 gauge vs 20 gauge pars plana vitrectomy.

Primary outcomes

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

    Time frame: 1 Year

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 29, 2012
Registry last updated
Dec 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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