Visual Perceptual Learning Based Digital Therapeutics for Stereopsis in Intermittent Exotropia

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.

Study Overview

• Status: Recruiting
• Conditions: Intermittent Exotropia
• Intervention / Treatment: Device: Nu.T; Other: No-Treatment Control

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dong-Wha Kang, MD, PhD; Phone Number: +82-2-488-6542; Email: dwk@nunaps.com

Study Locations

• Korea, Republic of
  • Goyang, Korea, Republic of
    • Recruiting
    • Inje University Ilsan Paik Hospital
    • Contact: Ji Woong Chang, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: Yeji Moon, MD, PhD
  • Seoul, Korea, Republic of
    • Recruiting
    • Konkuk University Hospital
    • Contact: Hyun Jin Shin, MD, PhD
  • Seoul, Korea, Republic of
    • Recruiting
    • Nowon Eulji Medical Center, Eulji University
    • Contact: Eun Hye Jung, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nu.T; Nu.T, 5 times a week for 8 weeks.	Device: Nu.T; Participants receive visual perceptual training using the Nu.T software.
Other: No-treatment Control; No-treatment was administered during control period.	Other: No-Treatment Control; No-treatment was administered during control period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in (log) arc second of stereopsis from Baseline to 8 weeks	Stereopsis will be evaluated by a Titmus Dot Test.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects showing improved stereopsis at 8 weeks compared to baseline	Improved stereopsis means more than 2 steps increase in Titmus Dot Test.	8 weeks
Changes of Stereopsis based on Titmus Symbol Test from baseline to 8 weeks	Stereopsis will be evaluated by Titmus Symbol Test.	8 weeks
Changes of Stereopsis based on Distance Randot Stereotest from baseline to 8 weeks	Stereopsis will be evaluated by Distance Randot Stereotest.	8 weeks
Changes of strabismus angle from baseline to 8 weeks	Strabismus angle will be evaluated by distance and near-field.	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.	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.	8 weeks

Collaborators and Investigators

• Sponsor: Nunaps Inc
• Investigators: Study Chair: Yeji Moon, MD, PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 25, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Exotropia
• Other Study ID Numbers: NNS-IXTS-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No