An observational study in Retinal Detachment, sponsored by Moorfields Eye Hospital NHS Foundation Trust. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-16.
Sponsored by Moorfields Eye Hospital NHS Foundation Trust · Observational
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.
207 studies on the registry are indexed under Retinal Detachment; 27 are open to participants now.
This study's enrollment of 262 is above the median of 64 across 60 observational studies indexed under Retinal Detachment.
Browse Retinal Detachment studies →Moorfields Eye Hospital NHS Foundation Trust is the lead sponsor of 48 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients presenting with macula-involving rhegmatogenous retinal detachment
Exclusion Criteria:
To posture in the face down position for the first 24 hours following surgery.
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.
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
Time frame: 26 Weeks
To assess the degree of retinal displacement on autofluorescence imaging
Degree of retinal displacement on autofluorescence imaging at 26 weeks
Time frame: 26 Weeks
To assess proportion of patients in each group with retinal displacement at 8 weeks
The proportion of patients in each group with retinal displacement at 8 weeks after surgery.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 26 Weeks
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.
Time frame: Eight and 26 weeks
To assess the persistence of post-operative distortion: paired comparisons of subjective & objective distortion at two separate time-points
Persistence of post-operative distortion: paired comparisons of subjective \& objective distortion at 8 and 26 weeks.
Time frame: 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.
Time frame: 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
Time frame: 26 Weeks
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Moorfields Eye Hospital NHS Foundation Trust