Clinical trial NCT02748538: The Posturing After Retinal Detachment (Post RD) Trial
Official title: A Randomised Controlled Trial to Evaluate the Effect of Face-down Posturing on Retinal Displacement and Distortion Following Retinal Detachment Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Detachment
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting with macula-involving rhegmatogenous retinal detachment

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess the proportion of patients in each treatment group with retinal displacement at 26 weeks after surgery
timeFrame: 26 Weeks
Secondary outcomes:
measure: To assess the degree of retinal displacement on autofluorescence imaging
timeFrame: 26 Weeks
measure: To assess proportion of patients in each group with retinal displacement at 8 weeks
timeFrame: Eight weeks
measure: To report the mean (SD)/median (IQR) ETDRS visual acuity score at two different time-points
timeFrame: Eight and 26 weeks
measure: To report the mean(SD)/median(IQR) Objective distortion score at two different time-points
timeFrame: Eight and 26 weeks
measure: To report the mean (SD) / median (IQR) Visual function score as measured using the Visual Function Questionnaire
timeFrame: 26 Weeks
Other outcomes:
measure: To assess subjective distortion by comparing patient's scores from the distortion questionnaire
timeFrame: Eight and 26 weeks
measure: To assess the persistence of post-operative distortion: paired comparisons of subjective & objective distortion at two separate time-points
timeFrame: Eight and 26 weeks
measure: To assess the correlation between retinal displacement and distortion
timeFrame: Eight or 26 weeks
measure: To assess the relationship of exploratory outcome parameters at 26 weeks to self-recorded posturing diary
timeFrame: 26 Weeks
Locations:
Study officials:
References:
citation: 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.