Visual Perceptual Learning Based Digital Therapeutics for Stereopsis in Intermittent Exotropia

Last updated: January 10, 2025
Sponsor: Nunaps Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

No-Treatment Control

Nu.T

Clinical Study ID

NCT06117813
NNS-IXTS-01
  • Ages 6-15
  • All Genders

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Incomitant strabismus patient with impaired eye movement

  • Patients with amblyopia (Maximal corrective vision of one eye is less than 0.8 ormaximal 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 onemonth for the purpose of treating strabismus or amblyopia

  • Scheduled for ophthalmic surgery during the clinical trial participation period (8weeks in the treatment group as of the registration date, Maximum 16 weeks in thecontrol 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, precludesparticipation in the trial

Study Design

Total Participants: 54
Treatment Group(s): 2
Primary Treatment: No-Treatment Control
Phase:
Study Start date:
December 22, 2023
Estimated Completion Date:
February 15, 2025

Connect with a study center

  • Inje University Ilsan Paik Hospital

    Goyang,
    Korea, Republic of

    Site Not Available

  • Hangil Eye Hospital

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Konkuk University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Nowon Eulji Medical Center, Eulji University

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Uijeongbu Eulji Medical Center, Eulji University

    Uijeongbu,
    Korea, Republic of

    Active - Recruiting

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