ClinicalTrials.gg
CompletedNCT06117813Updated Sep 18, 2025

Visual Perceptual Learning Based Digital Therapeutics for Stereopsis in Intermittent Exotropia

An interventional study of Nu.T and No-Treatment Control in Intermittent Exotropia, sponsored by Nunaps Inc. Completed at 6 sites in South Korea. Open to participants aged 6 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-09-18.

Sponsored by Nunaps Inc · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
6 Years to 15 Years
Sex
All
01

Study 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. The other half will not receive any training because there is no standard treatment for decreased stereopsis in intermittent exotropia.

02

Conditions studied

  • Intermittent Exotropia

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03

In context

Exotropia

58 studies on the registry are indexed under Exotropia; 13 are open to participants now.

This study's enrollment of 54 is close to the median of 50 across 49 interventional studies indexed under Exotropia.

Browse Exotropia studies →

Lead sponsor

Nunaps Inc is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 form

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Nu.T

    Nu.T, 5 times a week for 8 weeks.

    Device: Nu.T

  • Other
    No-treatment Control

    No-treatment was administered during control period.

    Other: No-Treatment Control

Interventions

  • DeviceNu.T

    Participants receive visual perceptual training using the Nu.T software.

  • OtherNo-Treatment Control

    No-treatment was administered during control period.

06

What researchers measure

Primary outcomes

  1. Changes in (log) arc second of stereopsis from Baseline to 8 weeks

    Stereopsis will be evaluated by a Titmus Dot Test.

    Time frame: 8 weeks

Secondary outcomes

  1. Proportion of subjects showing improved stereopsis at 8 weeks compared to baseline

    Improved stereopsis means more than 2 steps increase in Titmus Dot Test.

    Time frame: 8 weeks

  2. Changes of Stereopsis based on Titmus Symbol Test from baseline to 8 weeks

    Stereopsis will be evaluated by Titmus Symbol Test.

    Time frame: 8 weeks

  3. Changes of Stereopsis based on Distance Randot Stereotest from baseline to 8 weeks

    Stereopsis will be evaluated by Distance Randot Stereotest.

    Time frame: 8 weeks

  4. Changes of strabismus angle from baseline to 8 weeks

    Strabismus angle will be evaluated by distance and near-field.

    Time frame: 8 weeks

  5. 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.

    Time frame: 8 weeks

  6. 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.

    Time frame: 8 weeks

07

Study locations

6 sites
  • Inje University Ilsan Paik Hospital
    Goyang, South Korea
  • Hangil Eye Hospital
    Incheon, South Korea
  • Asan Medical Center
    Seoul, South Korea
  • Konkuk University Hospital
    Seoul, South Korea
  • Nowon Eulji Medical Center, Eulji University
    Seoul, South Korea
  • Uijeongbu Eulji Medical Center, Eulji University
    Uijeongbu-si, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06117813
Lead sponsor
Nunaps Inc
Responsible party
Sponsor
First posted
Nov 7, 2023
Start date
Dec 22, 2023
Primary completion
Jun 12, 2025
Completion
Jul 16, 2025
Last update
Sep 18, 2025

Study contacts

Yeji Moon, MD, PhD
study chair · Asan Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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