Clinical Trial: Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomised Controlled Trial Comparing Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Retinal Detachment; Anatomical Success, Functional Success and

Brief Summary: The purpose of this research study is to compare the outcomes of pneumatic retinopexy with the outcomes of vitrectomy (with or without scleral buckle) for the management of retinal detachment, in terms of anatomical success, functional success and impact on patient quality of life.

Detailed Summary: Rhegmatogenous retinal detachment (RRD)is an acute, sight threatening condition, with an incidence of approximately 10 per 100,000 population. Both of the treatments under investigation are widely used and accepted by vitreoretinal surgeons, but randomised, prospective comparison of the two techniques has not been reported in the scientific literature to date. Currently, the management decisions surrounding primary retinal detachment are grounded on a weak evidence base. The findings of this study will allow vitreoretinal surgeons and their patients to select the most appropriate intervention for that individual, in an informed and holistic manner.
Sponsor: St. Michael's Hospital, Toronto

Current Primary Outcome: Visual acuity [ Time Frame: 12 months post intervention ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Visual acuity [ Time Frame: 1 week, 1 month, 3 months and 6 months post intervention ]
  • Subjective visual function [ Time Frame: 3, 6 and 12 months post intervention ]
    Questionnaire
  • Anatomical success (complete retinal re-attachment) [ Time Frame: 3, 6 and 12 months post intervention ]
  • Subjective health related quality of life [ Time Frame: Baseline and 1 month post intervention ]
    Questionnaire


Original Secondary Outcome:

  • Visual acuity [ Time Frame: 1 week, 1 month and 3 months post intervention ]
  • Subjective visual function [ Time Frame: 3 and 12 months post intervention ]
    Questionnaire
  • Anatomical success (complete retinal re-attachment) [ Time Frame: 3 and 12 months post intervention ]
  • Subjective health related quality of life [ Time Frame: Baseline and 1 month post intervention ]
    Questionnaire


Information By: St. Michael's Hospital, Toronto

Dates:
Date Received: July 9, 2012
Date Started: August 2012
Date Completion: August 2015
Last Updated: July 30, 2015
Last Verified: July 2015