The Posturing After Retinal Detachment (Post RD) Trial

Retinal Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748538
• Other study ID #: CHAD1032
• Status: Completed
• Start date: May 17, 2016
• Est. completion date: May 1, 2018

Study information

• Verified date: March 2016
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Moorfields Eye Hospital NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Eight and 26 weeks
Other	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.	Eight and 26 weeks
Other	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.	Eight or 26 weeks
Other	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	26 Weeks
Primary	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	26 Weeks
Secondary	To assess the degree of retinal displacement on autofluorescence imaging	Degree of retinal displacement on autofluorescence imaging at 26 weeks	26 Weeks
Secondary	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.	Eight weeks
Secondary	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	Eight and 26 weeks
Secondary	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	Eight and 26 weeks
Secondary	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.	26 Weeks