Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment

Not Applicable

Completed

• Conditions: Rhegmatogenous Retinal Detachment
• Interventions: Procedure: Pneumatic retinopexy; Procedure: Vitrectomy

• Registration Number: NCT01639209
• Lead Sponsor: Unity Health Toronto

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 Timeline

• Study First Submitted: 2012-07-09
• Study First Submitted QC: 2012-07-11
• Study First Posted: 2012-07-12
• Study Start: 2012-08
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pneumatic retinopexy	Pneumatic retinopexy	-
Vitrectomy	Vitrectomy	-

Primary Outcome Measures

Name	Time	Method
Visual acuity	12 months post intervention

Secondary Outcome Measures

Name	Time	Method
Subjective visual function	3, 6 and 12 months post intervention	Questionnaire
Anatomical success (complete retinal re-attachment)	3, 6 and 12 months post intervention
Subjective health related quality of life	Baseline and 1 month post intervention	Questionnaire
Visual acuity	1 week, 1 month, 3 months and 6 months post intervention

Trial Locations

Locations (1)

Department of Ophthalmology, St Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada