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
  Purpose

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.


Condition Intervention
Rhegmatogenous Retinal Detachment
Procedure: Vitrectomy
Procedure: Pneumatic retinopexy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 12 months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 176
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitrectomy Procedure: Vitrectomy
Pars plana vitrectomy plus laser/cryotherapy
Experimental: Pneumatic retinopexy Procedure: Pneumatic retinopexy
Pneumatic retinopexy plus laser/cryotherapy

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639209

Contacts
Contact: Rajeev H Muni, FRCSC 416-867-7411 rajeev.muni@utoronto.ca
Contact: Roxane J Hillier, FRCOphth 416-867-7411 roxanehillier@gmail.com

Locations
Canada, Ontario
Department of Ophthalmology, St Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5C 2T2
Principal Investigator: Rajeev H Muni, FRCSC         
Principal Investigator: Roxane J Hillier, FRCOphth         
Sub-Investigator: Alan Berger, FRCSC         
Sub-Investigator: Louis Giavedoni, FRCSC         
Sub-Investigator: Filiberto Altomare, FRCSC         
Sub-Investigator: David Wong, FRCSC         
Sub-Investigator: Shelley Boyd, FRCSC         
Sub-Investigator: David Chow, FRCSC         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Rajeev H Muni, FRCSC St Michael's Hospital, Toronto, CANADA
Principal Investigator: Roxane J Hillier, FRCOphth St Michael's Hospital, Toronto, CANADA
  More Information

No publications provided

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01639209     History of Changes
Other Study ID Numbers: REB #12-031
Study First Received: July 9, 2012
Last Updated: July 22, 2013
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:
Retinal detachment
Pneumatic retinopexy
Vitrectomy

Additional relevant MeSH terms:
Retinal Detachment
Dissociative Disorders
Retinal Diseases
Eye Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014