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Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment

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ClinicalTrials.gov Identifier: NCT01639209
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Unity Health Toronto

Tracking Information
First Submitted Date  ICMJE July 9, 2012
First Posted Date  ICMJE July 12, 2012
Last Update Posted Date September 18, 2019
Actual Study Start Date  ICMJE August 2012
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2012)
Visual acuity [ Time Frame: 12 months post intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2012)
  • 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 Measures  ICMJE
 (submitted: July 11, 2012)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment
Official Title  ICMJE 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
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 Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rhegmatogenous Retinal Detachment
Intervention  ICMJE
  • Procedure: Vitrectomy
    Pars plana vitrectomy plus laser/cryotherapy
  • Procedure: Pneumatic retinopexy
    Pneumatic retinopexy plus laser/cryotherapy
Study Arms  ICMJE
  • Experimental: Vitrectomy
    Intervention: Procedure: Vitrectomy
  • Experimental: Pneumatic retinopexy
    Intervention: Procedure: Pneumatic retinopexy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2012)
176
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01639209
Other Study ID Numbers  ICMJE REB #12-031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Unity Health Toronto
Study Sponsor  ICMJE Unity Health Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rajeev H Muni, FRCSC St. Michael's Hospital (Toronto, Canada)
Principal Investigator: Roxane J Hillier, FRCOphth St. Michael's Hospital (Toronto, Canada)
PRS Account Unity Health Toronto
Verification Date September 2019

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