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

November 16, 2014 updated by: Zhi-zhong Ma, Peking University Third Hospital

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Hui-Jin Chen, M.D.
        • Sub-Investigator:
          • Hui-Jin Chen, M.D.
        • Principal Investigator:
          • Zhi-Zhong Ma, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: supine
postoperative postures: patients in this arm are assigned to adopt supine position for 24 hours after the surgery
Behavioral: postoperative postures
two postoperative postures: supine and temporal-lateral
Experimental: temporal lateral
postoperative postures: patients in this arm are assigned to adopt temporal lateral position for 24 hours after the surgery
Behavioral: postoperative postures
two postoperative postures: supine and temporal-lateral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Measures

Outcome Measure
Time Frame
best corrected visual acuity
Time Frame: 6 months after surgery
6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Study Director: Hui-Jin Chen, M.D., Peking University Third Hospital
  • Study Chair: Chang-Guan Wang, M.D., Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

October 11, 2014

First Submitted That Met QC Criteria

November 16, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 16, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PekingUTH-RD-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Retinal Detachment

Clinical Trials on postoperative postures

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe