Retinal DetachmentNCT02294708
The Influence of Postoperative Postures on Persistent Sub-foveal Fluid After Scleral Buckle Surgery
A study testing postoperative postures in people with Retinal Detachment, run by Peking University Third Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate whether postoperative postures influence persistent sub-foveal fluid after scleral buckle surgery Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- postoperative postures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Feb 2015
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- rhegmatogenous retinal detachment (RRD)
- macula off
- treated by successful scleral buckle surgery
- recent onset with symptom within 1 month
Who cannot join
- with failed previous surgery
- intraoperative or postoperative injection of long-acting gas
- with other eye diseases than RRD
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Hui-Jin Chen, M.D.
Hui-Jin Chen, M.D.
About this study
Official title: The Influence of Postoperative Postures on the Incidence and Duration of Persistent Sub-foveal Fluid After Scleral Buckle for Macula-off Retinal Detachment
The purpose of this study is to evaluate whether postoperative postures influence persistent sub-foveal fluid after scleral buckle surgery
Read the detailed description
In this study, we are to compare the difference of influence of two postoperative postures on the incidence and duration of persistent sub-foveal fluid after scleral buckle surgery for macula-off retinal detachment
- Conditions
- Retinal Detachment
- Being tested
- postoperative postures
- Keywords
- macula-off retinal detachment, scleral buckle, persistent sub-foveal fluid, postoperative postures, optical coherence tomography (OCT)
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative posturesBehavioural
two postoperative postures: supine and temporal-lateral
| Study group | Role | What they receive |
|---|---|---|
| supine | Experimental | postoperative postures: patients in this arm are assigned to adopt supine position for 24 hours after the surgery Receives: Behavioral: postoperative postures |
| temporal lateral | Experimental | postoperative postures: patients in this arm are assigned to adopt temporal lateral position for 24 hours after the surgery Receives: Behavioral: postoperative postures |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of absorption of persistent sub-foveal fluid after surgery
time interval from surgery to the date of disappearance of sub-foveal fluid on OCT
Measured: Time from the date of operation until the date of absorption of sub-foveal fluid determined by OCT. The estimated period of time over which the event (absorption of sub-foveal fluid ) is assessed is up to 1 year.
Secondary outcomes (1)
best corrected visual acuity
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi-zhong Ma, Peking University Third Hospital
- Investigators
- Hui-Jin Chen, M.D., Study director, Peking University Third HospitalChang-Guan Wang, M.D., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294708
- Sponsor's protocol ID
- PekingUTH-RD-2014
- Status last verified
- Nov 2014
- First submitted
- 11 Oct 2014
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Postoperative Postures on the Incidence and Duration of Persistent Sub-foveal Fluid After Scleral Buckle for Macula-off Retinal Detachment
- ClinicalTrials.gov ID
- NCT02294708
- Acronym / sponsor ID
- PekingUTH-RD-2014
- Conditions
- Retinal Detachment
- Keywords
- macula-off retinal detachment, scleral buckle, persistent sub-foveal fluid, postoperative postures, optical coherence tomography (OCT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 19 Nov 2014 (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.
The purpose of this study is to evaluate whether postoperative postures influence persistent sub-foveal fluid after scleral buckle surgery
Detailed description
In this study, we are to compare the difference of influence of two postoperative postures on the incidence and duration of persistent sub-foveal fluid after scleral buckle surgery for macula-off retinal detachment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supine | Experimental | Behavioral: postoperative posturespostoperative postures: patients in this arm are assigned to adopt supine position for 24 hours after the surgery |
| temporal lateral | Experimental | Behavioral: postoperative posturespostoperative postures: patients in this arm are assigned to adopt temporal lateral position for 24 hours after the surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- rhegmatogenous retinal detachment (RRD)
- macula off
- treated by successful scleral buckle surgery
- recent onset with symptom within 1 month
Key exclusion criteria (3 listed)
- with failed previous surgery
- intraoperative or postoperative injection of long-acting gas
- with other eye diseases than RRD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postoperative posturestwo postoperative postures: supine and temporal-lateral | Behavioural | supine, temporal lateral |
Primary outcome
duration of absorption of persistent sub-foveal fluid after surgery
Time frame: Time from the date of operation until the date of absorption of sub-foveal fluid determined by OCT. The estimated period of time over which the event (absorption of sub-foveal fluid ) is assessed is up to 1 year.
time interval from surgery to the date of disappearance of sub-foveal fluid on OCT
1 secondary outcome
best corrected visual acuity
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
Related trials for Retinal Detachment
RecruitingPhase 2
Prevention of ProliFerative Vitreoretinopathy With Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Recruiting
Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Stickler Syndrome Type 1, Stickler Syndrome Type 2
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
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.
Hui-Jin Chen, M.D. study director
Peking University Third Hospital
Chang-Guan Wang, M.D. study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postoperative postures in people with Retinal Detachment, run by Peking University Third Hospital at 1 site in China.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui-Jin Chen, M.D. (010-82666359, chjdoc@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of absorption of persistent sub-foveal fluid after surgery (time frame: Time from the date of operation until the date of absorption of sub-foveal fluid determined by OCT. The estimated period of time over which the event (absorption of sub-foveal fluid ) is assessed is up to 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2014.