Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by St. Michael's Hospital, Toronto
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01639209
First received: July 9, 2012
Last updated: July 22, 2013
Last verified: July 2013

July 9, 2012
July 22, 2013
August 2012
August 2014   (final data collection date for primary outcome measure)
Visual acuity [ Time Frame: 12 months post intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01639209 on ClinicalTrials.gov Archive Site
  • Visual acuity [ Time Frame: 1 week, 1 month, 3 months and 6 months post intervention ] [ Designated as safety issue: No ]
  • Subjective visual function [ Time Frame: 3, 6 and 12 months post intervention ] [ Designated as safety issue: No ]
    Questionnaire
  • Anatomical success (complete retinal re-attachment) [ Time Frame: 3, 6 and 12 months post intervention ] [ Designated as safety issue: No ]
  • Subjective health related quality of life [ Time Frame: Baseline and 1 month post intervention ] [ Designated as safety issue: No ]
    Questionnaire
  • Visual acuity [ Time Frame: 1 week, 1 month and 3 months post intervention ] [ Designated as safety issue: No ]
  • Subjective visual function [ Time Frame: 3 and 12 months post intervention ] [ Designated as safety issue: No ]
    Questionnaire
  • Anatomical success (complete retinal re-attachment) [ Time Frame: 3 and 12 months post intervention ] [ Designated as safety issue: No ]
  • Subjective health related quality of life [ Time Frame: Baseline and 1 month post intervention ] [ Designated as safety issue: No ]
    Questionnaire
Not Provided
Not Provided
 
Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment
A Randomised Controlled Trial Comparing Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Retinal Detachment; Anatomical Success, Functional Success and Impact on Patient Quality of Life

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rhegmatogenous Retinal Detachment
  • Procedure: Vitrectomy
    Pars plana vitrectomy plus laser/cryotherapy
  • Procedure: Pneumatic retinopexy
    Pneumatic retinopexy plus laser/cryotherapy
  • Experimental: Vitrectomy
    Intervention: Procedure: Vitrectomy
  • Experimental: Pneumatic retinopexy
    Intervention: Procedure: Pneumatic retinopexy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
176
August 2015
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients presenting with acute rhegmatogenous retinal detachment
  • Single retinal break OR group of breaks no larger than one clock hour (30°)
  • All break/s in detached retina between 8-4 o'clock
  • No significant proliferative vitreoretinopathy

Exclusion Criteria:

  • Inferior breaks in detached retina
  • Inability to read English language
  • Age < 18 years
  • Mental incapacity
  • Previous vitrectomy (index eye)
  • Previous retinal detachment (index eye)
  • Inability to maintain the post-operative posturing
  • Inability to carry out detailed examination of peripheral retina due to media opacity
Both
Not Provided
No
Contact: Rajeev H Muni, FRCSC 416-867-7411 rajeev.muni@utoronto.ca
Contact: Roxane J Hillier, FRCOphth 416-867-7411 roxanehillier@gmail.com
Canada
 
NCT01639209
REB #12-031
No
St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
Not Provided
Principal Investigator: Rajeev H Muni, FRCSC St Michael's Hospital, Toronto, CANADA
Principal Investigator: Roxane J Hillier, FRCOphth St Michael's Hospital, Toronto, CANADA
St. Michael's Hospital, Toronto
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP