- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01992510
The Effect of Postural Changes on Intraocular Pressure in Silicone Oil-filled Eyes
December 19, 2013 updated by: Dong Ho Park, Kyungpook National University Hospital
The study was conducted to investigate how postural changes including sitting, supine, and LDP(lateral decubitus position) affect the IOP(intraocular pressure) of SO(silicone oil-filled eyes.
In addition, this study compared the IOP changes between the SO-filled eyes and the fellow eyes in each body position.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
22
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jung-gu
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Daegu, Jung-gu, Korea, Republic of, 700-721
- Department of Ophthalmology, School of Medicine, Kyungpook National University
-
-
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
33 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
silicone tamponade patients
Description
Inclusion Criteria:
- patients who had a 23-gauge pars plana vitrectomy
- must be done with SO(silicone oil,5,000 centistrokes) endotamponade using the Accurus system (Alcon Laboratories, Inc, Hünenberg,Switzerland)
Exclusion Criteria:
- previous history or presence of glaucoma or uveitis
- IOP of ≥24 mmHg
- use of any antiglaucoma agents
- narrow angles
- corneal abnormality or diseases that could affect IOP
- refractive error exceeding a spherical equivalent of 6 diopters.
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
Cohorts and Interventions
Group / Cohort |
---|
silicone oil fiiled eye
those with a condition
|
fellow eye
the contralateral eye in the same patient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean IOP(intraocular pressure) at each time point during the change in body position
Time Frame: 100 minutes
|
100 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
IOP(intraocular pressure)differences between the SO(silicone oil)-filled eye and the fellow eyes at each time point during the change in body position
Time Frame: 100 minutes
|
100 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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, 2012
Primary Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
November 11, 2013
First Submitted That Met QC Criteria
November 22, 2013
First Posted (Estimate)
November 25, 2013
Study Record Updates
Last Update Posted (Estimate)
December 23, 2013
Last Update Submitted That Met QC Criteria
December 19, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- KNUH2013
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.
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