Back to results23 Gauge and 20 Gauge Vitrectomy for Rhegmatogenous Retinal Detachments
Primary Purpose
Retinal Detachment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Retinal Detachment repair
Sponsored by
About this trial
This is an interventional supportive care trial for Retinal Detachment focused on measuring RRD, Rhegmatogenous, Retinal, Detachment, PPV, Pars Plana Vitrectomy, Gauge
Eligibility 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.
Sites / Locations
- Mid Atlantic Retina
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
20 gauge pars plana vitrectomy
23 gauge pars plana vitrectomy
Arm Description
20 gauge pars plana vitrectomy for retinal detachment repair
23 gauge pars plana vitrectomy for retinal detachment repair
Outcomes
Primary Outcome Measures
Assess the initial retinal reattachment rates by comparing the percentages/amount.
Secondary Outcome Measures
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01716507
Brief Title
23 Gauge and 20 Gauge Vitrectomy for Rhegmatogenous Retinal Detachments
Official Title
A Prospective, Randomized Study Comparing 23-gauge and 20-gauge Pars Plana Vitrectomy for Repair of Pseudophakic Rhegmatogenous Retinal Detachments
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wills Eye
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
Keywords
RRD, Rhegmatogenous, Retinal, Detachment, PPV, Pars Plana Vitrectomy, Gauge
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
20 gauge pars plana vitrectomy
Arm Type
Other
Arm Description
20 gauge pars plana vitrectomy for retinal detachment repair
Arm Title
23 gauge pars plana vitrectomy
Arm Type
Other
Arm Description
23 gauge pars plana vitrectomy for retinal detachment repair
Intervention Type
Procedure
Intervention Name(s)
Retinal Detachment repair
Intervention Description
Comparing 23 gauge vs 20 gauge pars plana vitrectomy.
Primary Outcome Measure Information:
Title
Assess the initial retinal reattachment rates by comparing the percentages/amount.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Change in best-corrected visual acuity by comparing letters read.
Description
To determine the change in best-corrected visual acuity (BCVA) at the pre-operative visit compared to the 6 month post-operative visit
Time Frame
6 months
Title
Reattachment rates with 23 gauge and 20 gauge PPV by comparing the amount.
Description
To determine the final retinal reattachment rates with 23-gauge and 20-gauge PPV if multiple surgeries are required.
Time Frame
1 year
Title
Operating time for 23 gauge versus 20 gauge PPV (time measurement)
Description
This will be done to determine operating times for 23-gauge versus 20-gauge PPV for primary repair of PRD.
Time Frame
1 day- Day of surgery
Other Pre-specified Outcome Measures:
Title
Compare rates of intraoperative and postoperative complications by comparing the amount and severity of these complications.
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Hsu, MD
Organizational Affiliation
Wills Eye
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mid Atlantic Retina
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
23 Gauge and 20 Gauge Vitrectomy for Rhegmatogenous Retinal Detachments
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