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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

262

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients presenting with macula-involving rhegmatogenous retinal detachment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

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
Time Frame: 26 Weeks
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
Time Frame: 26 Weeks
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
Time Frame: Eight 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
Time Frame: 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
Eight and 26 weeks
To report the mean(SD)/median(IQR) Objective distortion score at two different time-points
Time Frame: 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
Eight and 26 weeks
To report the mean (SD) / median (IQR) Visual function score as measured using the Visual Function Questionnaire
Time Frame: 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.
26 Weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess subjective distortion by comparing patient's scores from the distortion questionnaire
Time Frame: Eight and 26 weeks
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
Time Frame: Eight and 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
Time Frame: 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.
Eight or 26 weeks
To assess the relationship of exploratory outcome parameters at 26 weeks to self-recorded posturing diary
Time Frame: 26 Weeks
Relationship of exploratory outcome parameters at 26 weeks to self-recorded posturing diary
26 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

April 21, 2016

First Posted (Estimate)

April 22, 2016

Study Record Updates

Last Update Posted (Actual)

May 16, 2018

Last Update Submitted That Met QC Criteria

May 10, 2018

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • CHAD1032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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