- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03641040
The Analysis of Ocular Deviations Between Dominant and Non-dominant Eye Using Video-oculography (VOG) in Intermittent Exotropia
August 21, 2018 updated by: Sung-Hyuk Moon, Inje University
Fifteen subjects with intermittent exotropia were included.
The subjects were asked to fixate on a black-on-white optotype at 1 m, which subtended a visual angle of 50 min of arc, equating to a Snellen optotype of 20/200.
The video files and data about ocular deviations were obtained using VOG with alternate cover test.
Investigators analyzed angles of ocular deviations in dominant and non-dominant eyes, compared with values of VOG and deviation angles of the alternative prism cover test.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
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 Locations
-
-
-
Busan, Korea, Republic of
- Busan Paik Hospital
-
-
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
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Visual acuity >= 1.0/1.0
- Intermittent exotropia
- Cooperative
Exclusion Criteria:
- Other eye disease
- Have hyperopia, myopia > 2 diopter
- Have horizontal strabismus > 50 prism diopter
- Not cooperative, no agree
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: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VOG group
Measurement: Video-oculography(VOG) measure and analyze angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover.
|
measure and analyze angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover.
|
Active Comparator: APCT group
Measurement: Alternative prism cover test(APCT) measure and analyze angles of ocular deviations between dominant and non-dominant eye using APCT
|
measure and analyze angles of ocular deviations between dominant and non-dominant eye using APCT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover
Time Frame: 2 weeks after approval
|
The angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover
|
2 weeks after approval
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
December 21, 2017
Primary Completion (Anticipated)
March 31, 2019
Study Completion (Anticipated)
March 31, 2020
Study Registration Dates
First Submitted
August 19, 2018
First Submitted That Met QC Criteria
August 19, 2018
First Posted (Actual)
August 21, 2018
Study Record Updates
Last Update Posted (Actual)
August 23, 2018
Last Update Submitted That Met QC Criteria
August 21, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IJ1357913579
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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