Dynamic Stereopsis in Intermittent Exotropia PatientsNCT04152122
A Novel Dynamic Random-dot Stereopsis Assessment to Measure the Stereopsis in Intermittent Exotropia
An observational study of Dynamic Stereopsis in Intermittent Exotropia Patients, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
A novel dynamic random-dot stereopsis test that included motion + disparity (MD), motion (M), and disparity (D), in which the disparity cues range from 200 to 1200 arc-seconds was used. Read more about this study
- Who is it for?
- Ages 5 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dynamic Stereopsis in Intermittent Exotropia Patients
- What is being tested?
- The dynamic stereopsis test
- How many people
- 133 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2017to 1 Jun 2018
- Phase
- Observational
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: A total of 83 cases X(T) patients and 50 normal subjects were enrolled in the study.
Who may be able to join
- X(T) groups were as follows:
- near and distance exodeviation angles greater than 5 prism degrees (PD) and alternate cover tests and X(T) diagnosis by an experienced doctor;
- between 5 and 30 years old;
- 0.0 or better best corrected visual acuity (BCVA; logMAR, log of the minimum angle of resolution);
- absence of other ocular disorders or other systemic diseases.
- Normal group were as follows:
Show all 10Show fewer
- between 5 and 30 years old;
- 0.0 or better logMAR BCVA;
- near and distance exodeviation angles less than 5 PD and alternate cover tests; and
- no history of any ocular pathology or systemic disease.
Who cannot join
- X(T) groups were as follows:
- near and distance exodeviation angles less than 5 prism degrees (PD)
- younger than 5 or older than 30 years old;
- less than 0.0 or better best corrected visual acuity (BCVA; logMAR, log of the minimum angle of resolution);
- has other ocular disorders or other systemic diseases.
- Normal group were as follows:
Show all 10Show fewer
- younger than 5 or older than 30 years old;
- less than 0.0 or better best corrected visual acuity (BCVA; logMAR, log of the minimum angle of resolution);
- near and distance exodeviation angles more than 5 PD and alternate cover tests;
- has history of any ocular pathology or systemic disease.
Trial locations and contacts
1 site in 1 country.
About this study
A novel dynamic random-dot stereopsis test that included motion + disparity (MD), motion (M), and disparity (D), in which the disparity cues range from 200 to 1200 arc-seconds was used. The characteristics of preoperative dynamic stereopsis in 83 intermittent exotropia patients and its associations with clinical features were analysed, and the prognosis was followed up on the 1st day and 2nd, 6th and 12nd months postoperatively.
- Being tested
- The dynamic stereopsis test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The dynamic stereopsis testDiagnostic test
The characteristics of preoperative dynamic stereopsis in 83 intermittent exotropia patients and its associations with clinical features were analysed, and the prognosis was followed up on the 1st day and 2nd, 6th and 12nd months postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent exotropia group | Intermittent exotropia group Receives: Diagnostic Test: The dynamic stereopsis test | |
| Normal group | Normal group Receives: Diagnostic Test: The dynamic stereopsis test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean reciprocal value of stereopsis
The mean reciprocal value of stereopsis on the 1st day
Measured: 1st day
The mean reciprocal value of stereopsis
The mean reciprocal value of stereopsis on the 2nd month
Measured: 2nd month
The mean reciprocal value of stereopsis
The mean reciprocal value of stereopsis on the 6th month
Measured: 6th month
The mean reciprocal value of stereopsis
The mean reciprocal value of stereopsis on the 6th month
Measured: 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Feb 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dynamic Stereopsis in Intermittent Exotropia PatientsStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152122
- Sponsor's protocol ID
- 2016MEKY032
- Status last verified
- Nov 2019
- First submitted
- 31 Oct 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A novel dynamic random-dot stereopsis test that included motion + disparity (MD), motion (M), and disparity (D), in which the disparity cues range from 200 to 1200 arc-seconds was used. The characteristics of preoperative dynamic stereopsis in 83 intermittent exotropia patients and its associations with clinical features were analysed, and the prognosis was followed up on the 1st day and 2nd, 6th and 12nd months postoperatively.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Dynamic Random-dot Stereopsis Assessment to Measure the Stereopsis in Intermittent Exotropia
- ClinicalTrials.gov ID
- NCT04152122
- Acronym / sponsor ID
- 2016MEKY032
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 5 Nov 2019 (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.
A novel dynamic random-dot stereopsis test that included motion + disparity (MD), motion (M), and disparity (D), in which the disparity cues range from 200 to 1200 arc-seconds was used. The characteristics of preoperative dynamic stereopsis in 83 intermittent exotropia patients and its associations with clinical features were analysed, and the prognosis was followed up on the 1st day and 2nd, 6th and 12nd months postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent exotropia group | – | Diagnostic Test: The dynamic stereopsis testIntermittent exotropia group |
| Normal group | – | Diagnostic Test: The dynamic stereopsis testNormal group |
Who may qualify
- Ages
- 5 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- A total of 83 cases X(T) patients and 50 normal subjects were enrolled in the study.
Key inclusion criteria (10 listed)
- near and distance exodeviation angles greater than 5 prism degrees (PD) and alternate cover tests and X(T) diagnosis by an experienced doctor;
- between 5 and 30 years old;
- 0.0 or better best corrected visual acuity (BCVA; logMAR, log of the minimum angle of resolution);
- absence of other ocular disorders or other systemic diseases.
- between 5 and 30 years old;
Key exclusion criteria (10 listed)
- near and distance exodeviation angles less than 5 prism degrees (PD)
- younger than 5 or older than 30 years old;
- less than 0.0 or better best corrected visual acuity (BCVA; logMAR, log of the minimum angle of resolution);
- has other ocular disorders or other systemic diseases.
- younger than 5 or older than 30 years old;
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 |
|---|---|---|
| The dynamic stereopsis testThe characteristics of preoperative dynamic stereopsis in 83 intermittent exotropia patients and its associations with clinical features were analysed, and the prognosis was followed up on the 1st day and 2nd, 6th and 12nd months postoperatively. | Diagnostic test | Intermittent exotropia group, Normal group |
Primary outcome
The mean reciprocal value of stereopsis
Time frame: 1st day
The mean reciprocal value of stereopsis on the 1st day
The mean reciprocal value of stereopsis
Time frame: 2nd month
The mean reciprocal value of stereopsis on the 2nd month
The mean reciprocal value of stereopsis
Time frame: 6th month
The mean reciprocal value of stereopsis on the 6th month
The mean reciprocal value of stereopsis
Time frame: 12th month
The mean reciprocal value of stereopsis on the 6th month
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 5 Nov 2019.
- Individual participant dataSharing planned: No. A novel dynamic random-dot stereopsis test that included motion + disparity (MD), motion (M), and disparity (D), in which the disparity cues range from 200 to 1200 arc-seconds was used. The characteristics of preoperative dynamic stereopsis in 83 intermittent exotropia patients and its associations with clinical features were analysed, and the prognosis was followed up on the 1st day and 2nd, 6th and 12nd months postoperatively.
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?
An observational study of Dynamic Stereopsis in Intermittent Exotropia Patients, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
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 10 inclusion and 10 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 5 Nov 2019. 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 China. 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 mean reciprocal value of stereopsis (time frame: 1st day). The study lists 4 primary outcomes in all. 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 5 Nov 2019.