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23 Gauge and 20 Gauge Vitrectomy for Rhegmatogenous Retinal Detachments

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wills Eye
ClinicalTrials.gov Identifier:
NCT01716507
First received: October 25, 2012
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention
Retinal Detachment
 Procedure: Retinal Detachment repair

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Prospective, Randomized Study Comparing 23-gauge and 20-gauge Pars Plana Vitrectomy for Repair of Pseudophakic Rhegmatogenous Retinal Detachments

Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • Assess the initial retinal reattachment rates by comparing the percentages/amount. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in best-corrected visual acuity by comparing letters read. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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) [ Time Frame: 1 day- Day of surgery ] [ Designated as safety issue: No ]
    This will be done to determine operating times for 23-gauge versus 20-gauge PPV for primary repair of PRD.


Other Outcome Measures:
  • Compare rates of intraoperative and postoperative complications by comparing the amount and severity of these complications. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 46
Study Start Date: April 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716507

Locations
United States, Pennsylvania
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Investigators
Principal Investigator: Jason Hsu, MD Wills Eye
  More Information

No publications provided

Responsible Party: Wills Eye
ClinicalTrials.gov Identifier: NCT01716507     History of Changes
Other Study ID Numbers: 23VS20RD, IRB08858
Study First Received: October 25, 2012
Last Updated: November 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Wills Eye:
RRD
Rhegmatogenous
Retinal
Detachment
 PPV
Pars Plana Vitrectomy
Gauge

Additional relevant MeSH terms:
Retinal Detachment
Dissociative Disorders
Retinal Diseases
Eye Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013