Retinal DetachmentNCT02748538
The Posturing After Retinal Detachment (Post RD) Trial
An observational study of Retinal Detachment, run by Moorfields Eye Hospital NHS Foundation Trust.
Trial summary
A randomised controlled trial to evaluate the effect of face-down posturing on retinal displacement and distortion following retinal detachment repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- How many people
- 262 participants
- Where
- No sites listed yet
- Study dates
- 17 May 2016to 1 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with macula-involving rhegmatogenous retinal detachment
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Randomised Controlled Trial to Evaluate the Effect of Face-down Posturing on Retinal Displacement and Distortion Following Retinal Detachment Repair
A randomised controlled trial to evaluate the effect of face-down posturing on retinal displacement and distortion following retinal detachment repair.
Read the detailed 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.
- Conditions
- Retinal Detachment
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 26 Weeks
Secondary outcomes (5)
To assess the degree of retinal displacement on autofluorescence imaging
Degree of retinal displacement on autofluorescence imaging at 26 weeks
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start17 May 2016
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748538
- Sponsor's protocol ID
- CHAD1032
- Status last verified
- Mar 2016
- First submitted
- 30 Mar 2016
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32297923
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Evaluate the Effect of Face-down Posturing on Retinal Displacement and Distortion Following Retinal Detachment Repair
- ClinicalTrials.gov ID
- NCT02748538
- Acronym / sponsor ID
- CHAD1032
- Conditions
- Retinal Detachment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 17 May 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomised controlled trial to evaluate the effect of face-down posturing on retinal displacement and distortion following retinal detachment repair.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with macula-involving rhegmatogenous retinal detachment
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
To assess the degree of retinal displacement on autofluorescence imaging
Time frame: 26 Weeks
To assess proportion of patients in each group with retinal displacement at 8 weeks
Time frame: Eight weeks
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) Objective distortion score at two different time-points
Time frame: Eight and 26 weeks
To report the mean (SD) / median (IQR) Visual function score as measured using the Visual Function Questionnaire
Time frame: 26 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Derived from this study: PubMed 32297923Casswell 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.
- Individual participant dataSharing planned: No
Related trials for Retinal Detachment
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Stickler Syndrome Type 1, Stickler Syndrome Type 2
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Intraoperative OCT Guidance of Intraocular Surgery II
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Ocular Hypotony and Refractive Predictability in RRD Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Detachment, run by Moorfields Eye Hospital NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the proportion of patients in each treatment group with retinal displacement at 26 weeks after surgery (time frame: 26 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02748538, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.