StrabismusNCT03119311
A Novel Diagnostic Method for Exotropia Using Video-oculography
A study testing Video-oculography and APCT in people with Strabismus and Exotropia, run by Inje University at 1 site in South Korea.
Trial summary
Thirty-four subjects with constant exotropia were included. Two independent ophthalmologists measured the angle of ocular deviation using alternate prism cover test (APCT). The video files and data with the changes in ocular deviation during the alternate cover test were obtained using video-oculography (VOG). Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Strabismus, Exotropia
- What is being tested?
- Video-oculography and APCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Apr 2017to 10 Jul 2017
- 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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- have horizontal strabismus, cooperative, visual acuity >= 1.0/1.0
Who cannot join
- have vertical strabimus> 5prism diopter, not cooperative, no agree
Trial locations and contacts
1 site in 1 country.
About this study
Thirty-four subjects with constant exotropia were included. Two independent ophthalmologists measured the angle of ocular deviation using alternate prism cover test (APCT). The video files and data with the changes in ocular deviation during the alternate cover test were obtained using video-oculography (VOG). To verify the accuracy of VOG, Investigator compared the value obtained using VOG and the angle of a rotating model eye, and subsequently made a new linear equation using these data. The calculated values obtained using VOG were compared with those obtained using APCT to determine the diagnostic accuracy of VOG.
- Conditions
- Strabismus, Exotropia
- Being tested
- Video-oculography, APCT
- Medical subject headings
- Strabismus, Exotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-oculographyDiagnostic test
Diagnostic Method for Exotropia Using Video-oculography
APCTDiagnostic test
alternative prism cover test
| Study group | Role | What they receive |
|---|---|---|
| VOG group | Experimental | Video-oculography Receives: Diagnostic Test: Video-oculography |
| APCT group | Active comparator | alternative prism cover test Receives: Diagnostic Test: APCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The angle of ocular deviation (degree,°) measured by VOG and PCT
strabismic angle (degree,°) measured by VOG and PCT
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 posted18 Apr 2017
- Study start25 Apr 2017
- Primary completion30 Jun 2017
- Study completion10 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrabismusStudies 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
- 34 participants (actual)
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
- NCT03119311
- Sponsor's protocol ID
- IJ1234567
- Status last verified
- Jul 2017
- First submitted
- 4 Apr 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Park N, Park B, Oh M, Moon S, Kim M. A quantitative analysis method for comitant exotropia using video-oculography with alternate cover. BMC Ophthalmol. 2018 Mar 22;18(1):80. doi: 10.1186/s12886-018-0747-9.
PubMed 29566654
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Diagnostic Method for Exotropia Using Video-oculography
- ClinicalTrials.gov ID
- NCT03119311
- Acronym / sponsor ID
- IJ1234567
- Conditions
- Strabismus, Exotropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 18 Apr 2017 (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.
Thirty-four subjects with constant exotropia were included. Two independent ophthalmologists measured the angle of ocular deviation using alternate prism cover test (APCT). The video files and data with the changes in ocular deviation during the alternate cover test were obtained using video-oculography (VOG). To verify the accuracy of VOG, Investigator compared the value obtained using VOG and the angle of a rotating model eye, and subsequently made a new linear equation using these data. The calculated values obtained using VOG were compared with those obtained using APCT to determine the diagnostic accuracy of VOG.
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-oculographyVideo-oculography |
| APCT group | Active comparator | Diagnostic Test: APCTalternative prism cover test |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- have horizontal strabismus, cooperative, visual acuity >= 1.0/1.0
Key exclusion criteria (1 listed)
- have vertical strabimus> 5prism 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-oculographyDiagnostic Method for Exotropia Using Video-oculography | Diagnostic test | VOG group |
| APCTalternative prism cover test | Diagnostic test | APCT group |
Primary outcome
The angle of ocular deviation (degree,°) measured by VOG and PCT
Time frame: 2 weeks after approval
strabismic angle (degree,°) measured by VOG and PCT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Derived from this study: PubMed 29566654Park N, Park B, Oh M, Moon S, Kim M. A quantitative analysis method for comitant exotropia using video-oculography with alternate cover. BMC Ophthalmol. 2018 Mar 22;18(1):80. doi: 10.1186/s12886-018-0747-9.
- 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 APCT in people with Strabismus and Exotropia, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Jul 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 angle of ocular deviation (degree,°) measured by VOG and PCT (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?
On the ClinicalTrials.gov record for NCT03119311, which also lists 1 linked publication.
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 21 Jul 2017.