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Completed

NCT Number: 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.

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Key information

Conditions

Retinal Detachment Eye Diseases Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. To assess the degree of retinal displacement on autofluorescence imaging

    Time frame: 26 Weeks

    Degree of retinal displacement on autofluorescence imaging at 26 weeks

  2. 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.

  3. 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

  4. 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

  5. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 22, 2016
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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