The Influence of Postoperative Postures on Persistent Sub-foveal Fluid After Scleral Buckle Surgery
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to evaluate whether postoperative postures influence persistent sub-foveal fluid after scleral buckle surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 11, 2014
CompletedFirst Posted
Study publicly available on registry
November 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedNovember 19, 2014
November 1, 2014
11 months
October 11, 2014
November 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
6 months after surgery
Study Arms (2)
supine
EXPERIMENTALpostoperative postures: patients in this arm are assigned to adopt supine position for 24 hours after the surgery
temporal lateral
EXPERIMENTALpostoperative postures: patients in this arm are assigned to adopt temporal lateral position for 24 hours after the surgery
Interventions
two postoperative postures: supine and temporal-lateral
Eligibility Criteria
You may qualify if:
- rhegmatogenous retinal detachment (RRD)
- macula off
- treated by successful scleral buckle surgery
- recent onset with symptom within 1 month
You may not qualify if:
- with failed previous surgery
- intraoperative or postoperative injection of long-acting gas
- with other eye diseases than RRD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospital
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hui-Jin Chen, M.D.
Peking University Third Hospital
- STUDY CHAIR
Chang-Guan Wang, M.D.
Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chair of ophthalmology department
Study Record Dates
First Submitted
October 11, 2014
First Posted
November 19, 2014
Study Start
January 1, 2014
Primary Completion
December 1, 2014
Study Completion
February 1, 2015
Last Updated
November 19, 2014
Record last verified: 2014-11