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Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by St. Michael's Hospital, Toronto.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto Identifier:
First received: July 9, 2012
Last updated: July 30, 2015
Last verified: July 2015
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
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 ]

Secondary Outcome Measures:
  • 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 ]

  • 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 ]

Estimated Enrollment: 176
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01639209

Contact: Rajeev H Muni, FRCSC 416-867-7411
Contact: Roxane J Hillier, FRCOphth 416-867-7411

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
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

Responsible Party: St. Michael's Hospital, Toronto Identifier: NCT01639209     History of Changes
Other Study ID Numbers: REB #12-031
Study First Received: July 9, 2012
Last Updated: July 30, 2015

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

Additional relevant MeSH terms:
Dissociative Disorders
Retinal Detachment
Mental Disorders
Retinal Diseases
Eye Diseases processed this record on July 25, 2017