Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Rhegmatogenous Retinal Detachment

Intervention / Treatment
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* Procedure: Vitrectomy
* Procedure: Pneumatic retinopexy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitrectomy<br> | Procedure: Vitrectomy<br>* Pars plana vitrectomy plus laser/cryotherapy<br>|
| Experimental: Pneumatic retinopexy<br> | Procedure: Pneumatic retinopexy<br>* Pneumatic retinopexy plus laser/cryotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 12 months post intervention | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinal detachment, Pneumatic retinopexy, Vitrectomy