Intermittent ExotropiaNCT03641040
The Analysis of Ocular Deviations Between Dominant and Non-dominant Eye Using Video-oculography (VOG) in Intermittent Exotropia
A study testing Video-oculography and Alternative prism cover test in people with Intermittent Exotropia and Strabismus, run by Inje University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intermittent Exotropia, Strabismus
- What is being tested?
- Video-oculography and Alternative prism cover test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Dec 2017to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Visual acuity >= 1.0/1.0
- Intermittent exotropia
- Cooperative
Who cannot join
- Other eye disease
- Have hyperopia, myopia > 2 diopter
- Have horizontal strabismus > 50 prism diopter
- Not cooperative, no agree
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Intermittent Exotropia, Strabismus
- Being tested
- Video-oculography, Alternative prism cover test
- Keywords
- Video-oculography, Intermittent exotropia, ocular deviation
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-oculographyDiagnostic test
measure and analyze angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover.
Alternative prism cover testDiagnostic test
measure and analyze angles of ocular deviations between dominant and non-dominant eye using APCT
| Study group | Role | What they receive |
|---|---|---|
| VOG group | Experimental | Measurement: Video-oculography(VOG) measure and analyze angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover. Receives: Diagnostic Test: Video-oculography |
| APCT group | Active comparator | Measurement: Alternative prism cover test(APCT) measure and analyze angles of ocular deviations between dominant and non-dominant eye using APCT Receives: Diagnostic Test: Alternative prism cover test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover
The angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover
Measured: 2 weeks after approval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start21 Dec 2017
- Primary completion31 Mar 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ExotropiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Hyuk Moon, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641040
- Sponsor's protocol ID
- IJ1357913579
- Status last verified
- Aug 2018
- First submitted
- 19 Aug 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analysis of Ocular Deviations Between Dominant and Non-dominant Eye Using Video-oculography (VOG) in Intermittent Exotropia
- ClinicalTrials.gov ID
- NCT03641040
- Acronym / sponsor ID
- IJ1357913579
- Conditions
- Intermittent Exotropia, Strabismus
- Keywords
- Video-oculography, Intermittent exotropia, ocular deviation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VOG group | Experimental | Diagnostic Test: Video-oculographyMeasurement: Video-oculography(VOG) measure and analyze angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover. |
| APCT group | Active comparator | Diagnostic Test: Alternative prism cover testMeasurement: Alternative prism cover test(APCT) measure and analyze angles of ocular deviations between dominant and non-dominant eye using APCT |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Visual acuity >= 1.0/1.0
- Intermittent exotropia
- Cooperative
Key exclusion criteria (4 listed)
- Other eye disease
- Have hyperopia, myopia > 2 diopter
- Have horizontal strabismus > 50 prism diopter
- Not cooperative, no agree
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-oculographymeasure and analyze angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover. | Diagnostic test | VOG group |
| Alternative prism cover testmeasure and analyze angles of ocular deviations between dominant and non-dominant eye using APCT | Diagnostic test | APCT group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-oculography and Alternative prism cover test in people with Intermittent Exotropia and Strabismus, run by Inje University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover (time frame: 2 weeks after approval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.