- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02748538
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
Study Overview
Status
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHAD1032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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