Visual Perceptual Learning Based Digital Therapeutics for... | NCT06117813

Studies
Visual Perceptual Learning Based Digital Therapeutics for Stereopsis in Intermittent Exotropia

NCT06117813

Sponsor

Nunaps Inc

Status

Completed

Last Update Posted

Sep 18, 2025Actual

Enrollment

54Actual

Phase

Not Applicable

Conditions

Intermittent Exotropia

Interventions

Nu.T
No-Treatment Control

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 22, 2023Actual

Primary Completion Date

Jun 12, 2025Actual

Completion Date

Jul 16, 2025Actual

First Submitted Date

Oct 30, 2023

First Submission Date that Met QC Criteria

Nov 3, 2023

First Posted Date

Nov 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2025

Last Update Posted Date

Sep 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nu.T	Experimental	Nu.T, 5 times a week for 8 weeks.	Device: Nu.T
No-treatment Control	Other	No-treatment was administered during control period.	Other: No-Treatment Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nu.T	Device	Participants receive visual perceptual training using the Nu.T software.	Nu.T

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Inje University Ilsan Paik Hospital		Goyang			South Korea
Hangil Eye Hospital