Intermittent ExotropiaNCT06117813
Visual Perceptual Learning Based Digital Therapeutics for Stereopsis in Intermittent Exotropia
A study testing Nu.T in people with Intermittent Exotropia, run by Nunaps Inc at 6 sites in South Korea.
Trial summary
This study evaluates the efficacy and safety of visual perceptual learning for improving stereopsis in intermittent exotropia. Half of participants will receive visual perceptual training using the Nu.T. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Intermittent Exotropia
- What is being tested?
- Nu.T
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 22 Dec 2023to 16 Jul 2025
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Intermittent Exotropia patients aged 6 to 15
- Patients with decreased stereopsis above 50 arc seconds in Titmus Dot Test
- Able to use the Virtual Reality(VR) device
- Patient or legally authorized representative has signed the informed consent form
Who cannot join
- Incomitant strabismus patient with impaired eye movement
- Patients with amblyopia (Maximal corrective vision of one eye is less than 0.8 or maximal corrective vision both eyes more than two lines of difference)
- History of ophthalmic surgery
- Patient who has undergone or is currently undergoing cover treatment within one month for the purpose of treating strabismus or amblyopia
- Scheduled for ophthalmic surgery during the clinical trial participation period (8 weeks in the treatment group as of the registration date, Maximum 16 weeks in the control group as of the registration date)
- Difficult to understand and perform the stereopsis test.
Show all 11Show fewer
- Abnormal Retinal Correspondence
- Patient with neurological abnormalities other than strabismus
- History of premature birth
- Participating in other clinical trial
- Any other condition that, in the opinion of the investigator, precludes participation in the trial
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Inje University Ilsan Paik Hospital
Goyang
Hangil Eye Hospital
Incheon
Asan Medical Center
Seoul
Konkuk University Hospital
Seoul
Nowon Eulji Medical Center, Eulji University
Seoul
Uijeongbu Eulji Medical Center, Eulji University
Uijeongbu-si
About this study
Official title: Efficacy and Safety of the Nu.T for Improving Impaired Stereopsis Caused by Intermittent Exotropia : Multi Center, Randomized, Single-blind (Evaluator), Prospective Confirmatory Study
This study evaluates the efficacy and safety of visual perceptual learning for improving stereopsis in intermittent exotropia. Half of participants will receive visual perceptual training using the Nu.T. The other half will not receive any training because there is no standard treatment for decreased stereopsis in intermittent exotropia.
- Conditions
- Intermittent Exotropia
- Being tested
- Nu.T, No-Treatment Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nu.TDevice
Participants receive visual perceptual training using the Nu.T software.
No-Treatment ControlOther
No-treatment was administered during control period.
| Study group | Role | What they receive |
|---|---|---|
| Nu.T | Experimental | Nu.T, 5 times a week for 8 weeks. Receives: Device: Nu.T |
| No-treatment Control | Other | No-treatment was administered during control period. Receives: Other: No-Treatment Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in (log) arc second of stereopsis from Baseline to 8 weeks
Stereopsis will be evaluated by a Titmus Dot Test.
Measured: 8 weeks
Secondary outcomes (6)
Proportion of subjects showing improved stereopsis at 8 weeks compared to baseline
Improved stereopsis means more than 2 steps increase in Titmus Dot Test.
Measured: 8 weeks
Changes of Stereopsis based on Titmus Symbol Test from baseline to 8 weeks
Stereopsis will be evaluated by Titmus Symbol Test.
Measured: 8 weeks
Changes of Stereopsis based on Distance Randot Stereotest from baseline to 8 weeks
Stereopsis will be evaluated by Distance Randot Stereotest.
Measured: 8 weeks
Changes of strabismus angle from baseline to 8 weeks
Strabismus angle will be evaluated by distance and near-field.
Measured: 8 weeks
Changes of convergence capability score from baseline to 8 weeks
Convergence capability will be evaluated in distance and near-field by LACTOSE System. The scores by LACTOSE System range from 0 to 4.
Measured: 8 weeks
Changes of visuo-motor function from baseline to 8 weeks.
Visuo-motor function will be evaluated by the Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2) test.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start22 Dec 2023
- Primary completion12 Jun 2025
- Study completion16 Jul 2025
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nunaps Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yeji Moon, MD, PhD, Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117813
- Sponsor's protocol ID
- NNS-IXTS-01
- Status last verified
- Sep 2025
- First submitted
- 30 Oct 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Nu.T for Improving Impaired Stereopsis Caused by Intermittent Exotropia : Multi Center, Randomized, Single-blind (Evaluator), Prospective Confirmatory Study
- ClinicalTrials.gov ID
- NCT06117813
- Acronym / sponsor ID
- NNS-IXTS-01
- Conditions
- Intermittent Exotropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Nunaps IncIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 7 Nov 2023 (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.
This study evaluates the efficacy and safety of visual perceptual learning for improving stereopsis in intermittent exotropia. Half of participants will receive visual perceptual training using the Nu.T. The other half will not receive any training because there is no standard treatment for decreased stereopsis in intermittent exotropia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nu.T | Experimental | Device: Nu.TNu.T, 5 times a week for 8 weeks. |
| No-treatment Control | Other | Other: No-Treatment ControlNo-treatment was administered during control period. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Intermittent Exotropia patients aged 6 to 15
- Patients with decreased stereopsis above 50 arc seconds in Titmus Dot Test
- Able to use the Virtual Reality(VR) device
- Patient or legally authorized representative has signed the informed consent form
Key exclusion criteria (11 listed)
- Incomitant strabismus patient with impaired eye movement
- Patients with amblyopia (Maximal corrective vision of one eye is less than 0.8 or maximal corrective vision both eyes more than two lines of difference)
- History of ophthalmic surgery
- Patient who has undergone or is currently undergoing cover treatment within one month for the purpose of treating strabismus or amblyopia
- Scheduled for ophthalmic surgery during the clinical trial participation period (8 weeks in the treatment group as of the registration date, Maximum 16 weeks in the control group as of the registration date)
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 |
|---|---|---|
| Nu.TParticipants receive visual perceptual training using the Nu.T software. | Device | Nu.T |
| No-Treatment ControlNo-treatment was administered during control period. | Other | No-treatment Control |
Primary outcome
Changes in (log) arc second of stereopsis from Baseline to 8 weeks
Time frame: 8 weeks
Stereopsis will be evaluated by a Titmus Dot Test.
6 secondary outcomes
Proportion of subjects showing improved stereopsis at 8 weeks compared to baseline
Time frame: 8 weeks
Changes of Stereopsis based on Titmus Symbol Test from baseline to 8 weeks
Time frame: 8 weeks
Changes of Stereopsis based on Distance Randot Stereotest from baseline to 8 weeks
Time frame: 8 weeks
Changes of strabismus angle from baseline to 8 weeks
Time frame: 8 weeks
Changes of convergence capability score from baseline to 8 weeks
Time frame: 8 weeks
Changes of visuo-motor function from baseline to 8 weeks.
Time frame: 8 weeks
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 18 Sep 2025.
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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.
Yeji Moon, MD, PhD study chair
Asan Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nu.T in people with Intermittent Exotropia, run by Nunaps Inc at 6 sites 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 4 inclusion and 11 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 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Changes in (log) arc second of stereopsis from Baseline to 8 weeks (time frame: 8 weeks). 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 18 Sep 2025.