The Posturing After Retinal Detachment (Post RD) Trial

Study Overview
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Brief Summary
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A randomised controlled trial to evaluate the effect of face-down posturing on retinal displacement and distortion following retinal detachment repair.

Detailed Description
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During the surgical repair of a retina detachment, a gas bubble is inserted into the eye to keep the retina flat. Following this, it is common to ask patients to adopt a certain head position for a set period of time after their operation. This is known as posturing. It is thought that by adopting a certain head position/posturing, the bubble aids re-attachment of the retina. However, when the retinal detachment involves the macula (central portion of the retina) it has been shown that the retina can shift (or displace) post-operatively, leading to distortion in the patient's vision. The purpose of this study is to investigate whether adopting different head positions following surgery for macula involving retinal detachments, can reduce retinal displacement and visual distortion. The investigators plan to recruit 368 patients. Patients will be in follow up for a period of six months. The study will be operational at two different hospitals in the United Kingdom.

Official Title
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A Randomised Controlled Trial to Evaluate the Effect of Face-down Posturing on Retinal Displacement and Distortion Following Retinal Detachment Repair

Conditions
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Retinal Detachment

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fovea-involving rhegmatogenous retinal detachment History of central visual loss within the past 14 days Patients undergoing vitrectomy and gas surgery, under local anaesthetic Able to give informed consent 18 years old and over Exclusion Criteria: Previous vitrectomy or cryo-buckle surgery Retinal detachment surgery requiring silicone oil tamponade Existing ophthalmic condition which limits the patient's visual acuity (BCVA 6/36 or worse) Inability to posture post-operatively or commit to follow-up visits

Ages Eligible for Study
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Minimum Age: 18 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Face Down<br>To posture in the face down position for the first 24 hours following surgery. | |
| Position to Support the Break<br>The head is positioned so that the retinal breaks (which caused the retinal detachment) are positioned at the highest point of the eye and well supported by the intra-ocular gas bubble left within the eye at the completion of surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the proportion of patients in each treatment group with retinal displacement at 26 weeks after surgery | The proportion of patients in each treatment group with retinal displacement at 26 weeks after surgery | 26 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the degree of retinal displacement on autofluorescence imaging | Degree of retinal displacement on autofluorescence imaging at 26 weeks | 26 Weeks | 
| To assess proportion of patients in each group with retinal displacement at 8 weeks | The proportion of patients in each group with retinal displacement at 8 weeks after surgery. | Eight weeks | 
| To report the mean (SD)/median (IQR) ETDRS visual acuity score at two different time-points | To report the mean (SD)/median (IQR) ETDRS visual acuity score at 8 and 26 weeks after surgery in each treatment group | Eight and 26 weeks | 
| To report the mean(SD)/median(IQR) Objective distortion score at two different time-points | To report the mean(SD)/median(IQR) Objective distortion score at 8 and 26 weeks after surgery in each treatment group - with Objective distortion measured with D Charts | Eight and 26 weeks | 
| To report the mean (SD) / median (IQR) Visual function score as measured using the Visual Function Questionnaire | To report the mean (SD) / median (IQR) Visual function score as measured using the Visual Function Questionnaire (NEI Visual Function Questionnaire 25) in each treatment group at 26 weeks after surgery. | 26 Weeks |