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Completed

NCT Number: NCT06117813

Visual Perceptual Learning Based Digital Therapeutics for Stereopsis in Intermittent Exotropia

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.

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Key information

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inje University Ilsan Paik Hospital, Goyang, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent form

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

Treatment and study plan

Nu.T

Device

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

No-treatment control

Other

No-treatment was administered during control period.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 8 weeks

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

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

    Time frame: 8 weeks

    Stereopsis will be evaluated by Titmus Symbol Test.

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

    Time frame: 8 weeks

    Stereopsis will be evaluated by Distance Randot Stereotest.

  4. Changes of strabismus angle from baseline to 8 weeks

    Time frame: 8 weeks

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

  5. Changes of convergence capability score from baseline to 8 weeks

    Time frame: 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.

  6. Changes of visuo-motor function from baseline to 8 weeks.

    Time frame: 8 weeks

    Visuo-motor function will be evaluated by the Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2) test.

Sponsors and collaborators

Lead sponsor

Nunaps Inc

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2023
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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