We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01639209
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Rhegmatogenous Retinal Detachment Procedure: Vitrectomy Procedure: Pneumatic retinopexy

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : August 2012
Primary Completion Date : May 2017
Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Vitrectomy Procedure: Vitrectomy
Pars plana vitrectomy plus laser/cryotherapy
Experimental: Pneumatic retinopexy Procedure: Pneumatic retinopexy
Pneumatic retinopexy plus laser/cryotherapy


Outcome Measures

Primary Outcome Measures :
  1. Visual acuity [ Time Frame: 12 months post intervention ]

Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: 1 week, 1 month, 3 months and 6 months post intervention ]
  2. Subjective visual function [ Time Frame: 3, 6 and 12 months post intervention ]
    Questionnaire

  3. Anatomical success (complete retinal re-attachment) [ Time Frame: 3, 6 and 12 months post intervention ]
  4. Subjective health related quality of life [ Time Frame: Baseline and 1 month post intervention ]
    Questionnaire


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639209


Locations
Canada, Ontario
Department of Ophthalmology, St Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2
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

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01639209     History of Changes
Other Study ID Numbers: REB #12-031
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

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

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