The Posturing After Retinal Detachment (Post RD) Trial

NCT02748538 | Completed

• 1 other identifier: CHAD1032
• Study Type: observational
• Target: 262
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Retinal Detachment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• To assess the degree of retinal displacement on autofluorescence imaging

  26 Weeks

• To assess proportion of patients in each group with retinal displacement at 8 weeks

  Eight weeks

• To report the mean (SD)/median (IQR) ETDRS visual acuity score at two different time-points

  Eight and 26 weeks

• To report the mean(SD)/median(IQR) Objective distortion score at two different time-points

  Eight and 26 weeks

• To report the mean (SD) / median (IQR) Visual function score as measured using the Visual Function Questionnaire

  26 Weeks

Other Outcomes (4)

• To assess subjective distortion by comparing patient's scores from the distortion questionnaire

  Eight and 26 weeks

• To assess the persistence of post-operative distortion: paired comparisons of subjective & objective distortion at two separate time-points

  Eight and 26 weeks

• To assess the correlation between retinal displacement and distortion

  Eight or 26 weeks

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting with macula-involving rhegmatogenous retinal detachment

You may qualify if:

• 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
• years old and over

You may not qualify if:

• 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

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead

Related Publications (1)

• Casswell EJ, Yorston D, Lee E, Heeren TFC, Harris N, Zvobgo TM, Tarafdar S, Xing W, Bourmpaki E, Bunce C, Keane P, Charteris DG. Effect of Face-Down Positioning vs Support-the-Break Positioning After Macula-Involving Retinal Detachment Repair: The PostRD Randomized Clinical Trial. JAMA Ophthalmol. 2020 Jun 1;138(6):634-642. doi: 10.1001/jamaophthalmol.2020.0997.

  PMID: 32297923 DERIVED

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 22, 2016
• Study Start: May 17, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 16, 2018

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share