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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Face Down | To posture in the face down position for the first 24 hours following surgery. | ||
| Position to Support the Break | 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. |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess subjective distortion by comparing patient's scores from the distortion questionnaire | Subjective distortion: a comparison of patient's scores in the distortion questionnaire at 8 & 26 weeks. | Eight and 26 weeks |
| To assess the persistence of post-operative distortion: paired comparisons of subjective & objective distortion at two separate time-points |
Inclusion Criteria:
Exclusion Criteria:
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Patients presenting with macula-involving rhegmatogenous retinal detachment
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32297923 | Derived | Casswell EJ, Yorston D, Lee E, Heeren TFC, Harris N, Zvobgo TM, Tarafdar S, Xing W, Bourmpaki E, Bunce C, Keane P, Charteris DG. Effect of Face-Down Positioning vs Support-the-Break Positioning After Macula-Involving Retinal Detachment Repair: The PostRD Randomized Clinical Trial. JAMA Ophthalmol. 2020 Jun 1;138(6):634-642. doi: 10.1001/jamaophthalmol.2020.0997. |
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| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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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 |
Persistence of post-operative distortion: paired comparisons of subjective & objective distortion at 8 and 26 weeks. |
| Eight and 26 weeks |
| To assess the correlation between retinal displacement and distortion | Correlation between retinal displacement and distortion: the correlation between the incidence retinal displacement on autofluorescence imaging and distortion (questionnaire and D chart assessments) at 8 or 26 weeks. | Eight or 26 weeks |
| To assess the relationship of exploratory outcome parameters at 26 weeks to self-recorded posturing diary | Relationship of exploratory outcome parameters at 26 weeks to self-recorded posturing diary | 26 Weeks |