search
Back to results

The Influence of Postoperative Postures on Persistent Sub-foveal Fluid After Scleral Buckle Surgery

Primary Purpose

Retinal Detachment

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
postoperative postures
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Detachment focused on measuring macula-off retinal detachment, scleral buckle, persistent sub-foveal fluid, postoperative postures, optical coherence tomography (OCT)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • rhegmatogenous retinal detachment (RRD)
  • macula off
  • treated by successful scleral buckle surgery
  • recent onset with symptom within 1 month

Exclusion Criteria:

  • with failed previous surgery
  • intraoperative or postoperative injection of long-acting gas
  • with other eye diseases than RRD

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

supine

temporal lateral

Arm Description

postoperative postures: patients in this arm are assigned to adopt supine position for 24 hours after the surgery

postoperative postures: patients in this arm are assigned to adopt temporal lateral position for 24 hours after the surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

best corrected visual acuity

Full Information

First Posted
October 11, 2014
Last Updated
November 16, 2014
Sponsor
Peking University Third Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02294708
Brief Title
The Influence of Postoperative Postures on Persistent Sub-foveal Fluid After Scleral Buckle Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
Keywords
macula-off retinal detachment, scleral buckle, persistent sub-foveal fluid, postoperative postures, optical coherence tomography (OCT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
supine
Arm Type
Experimental
Arm Description
postoperative postures: patients in this arm are assigned to adopt supine position for 24 hours after the surgery
Arm Title
temporal lateral
Arm Type
Experimental
Arm Description
postoperative postures: patients in this arm are assigned to adopt temporal lateral position for 24 hours after the surgery
Intervention Type
Behavioral
Intervention Name(s)
postoperative postures
Intervention Description
two postoperative postures: supine and temporal-lateral
Primary Outcome Measure Information:
Title
duration of absorption of persistent sub-foveal fluid after surgery
Description
time interval from surgery to the date of disappearance of sub-foveal fluid on OCT
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.
Secondary Outcome Measure Information:
Title
best corrected visual acuity
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: rhegmatogenous retinal detachment (RRD) macula off treated by successful scleral buckle surgery recent onset with symptom within 1 month Exclusion Criteria: with failed previous surgery intraoperative or postoperative injection of long-acting gas with other eye diseases than RRD
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Jin Chen, M.D.
Phone
010-82666359
Email
chjdoc@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Jin Chen, M.D.
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chang-Guan Wang, M.D.
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Jin Chen, M.D.
First Name & Middle Initial & Last Name & Degree
Hui-Jin Chen, M.D.
First Name & Middle Initial & Last Name & Degree
Zhi-Zhong Ma, M.D.

12. IPD Sharing Statement

Learn more about this trial

The Influence of Postoperative Postures on Persistent Sub-foveal Fluid After Scleral Buckle Surgery

We'll reach out to this number within 24 hrs