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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02294708
Other study ID # PekingUTH-RD-2014
Secondary ID
Status Recruiting
Phase N/A
First received October 11, 2014
Last updated November 16, 2014
Start date January 2014
Est. completion date February 2015

Study information

Verified date November 2014
Source Peking University Third Hospital
Contact Hui-Jin Chen, M.D.
Phone 010-82666359
Email chjdoc@aliyun.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether postoperative postures influence persistent sub-foveal fluid after scleral buckle surgery


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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date February 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
postoperative postures
two postoperative postures: supine and temporal-lateral

Locations

Country Name City State
China Peking University Third Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
Secondary best corrected visual acuity 6 months after surgery No
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