Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment
This study is currently recruiting participants.
Verified October 2012 by St. Michael's Hospital, Toronto
Sponsor:
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01639209
First received: July 9, 2012
Last updated: October 9, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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
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: | October 9, 2012 |
| 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 May 19, 2013