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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
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Dissociative Disorders
Retinal Detachment
Eye Diseases
Mental Disorders
Retinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014