The Posturing After Retinal Detachment (Post RD) Trial

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02748538

Enrollment

262

Registered

2016-04-22

Start date

2016-05-17

Completion date

2018-05-01

Last updated

2018-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame	Description
To assess the correlation between retinal displacement and distortion	Eight or 26 weeks	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.
To assess the relationship of exploratory outcome parameters at 26 weeks to self-recorded posturing diary	26 Weeks	Relationship of exploratory outcome parameters at 26 weeks to self-recorded posturing diary
To assess the persistence of post-operative distortion: paired comparisons of subjective & objective distortion at two separate time-points	Eight and 26 weeks	Persistence of post-operative distortion: paired comparisons of subjective & objective distortion at 8 and 26 weeks.
To assess subjective distortion by comparing patient's scores from the distortion questionnaire	Eight and 26 weeks	Subjective distortion: a comparison of patient's scores in the distortion questionnaire at 8 & 26 weeks.

Outcome results