23 Gauge and 20 Gauge Vitrectomy for Rhegmatogenous Retinal Detachments

Study Overview
=================
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.

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

Conditions
-----------------
Retinal Detachment

Intervention / Treatment
-----------------
* Procedure: Retinal Detachment repair


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 20 gauge pars plana vitrectomy<br>20 gauge pars plana vitrectomy for retinal detachment repair | Procedure: Retinal Detachment repair<br>* Comparing 23 gauge vs 20 gauge pars plana vitrectomy.<br>|
| Other: 23 gauge pars plana vitrectomy<br>23 gauge pars plana vitrectomy for retinal detachment repair | Procedure: Retinal Detachment repair<br>* Comparing 23 gauge vs 20 gauge pars plana vitrectomy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the initial retinal reattachment rates by comparing the percentages/amount. |  | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 
| 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. | 1 year | 
| 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. | 1 day- Day of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RRD, Rhegmatogenous, Retinal, Detachment, PPV, Pars Plana Vitrectomy, Gauge