The Posturing After Retinal Detachment (Post RD) Trial

NCT ID: NCT02748538

Last Updated: 2018-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

262 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-17

Study Completion Date

2018-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinal Detachment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Face Down

To posture in the face down position for the first 24 hours following surgery.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Moorfields Eye Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32297923 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHAD1032

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.