Efficacy and Safety of the Nu.T for Improving Impaired Stereopsis Caused by Intermittent Exotropia : Multi Center, Randomized, Single-blind (Evaluator), Prospective Confirmatory Study

Nunaps Inc6 sites in 1 country54 target enrollmentDecember 22, 2023

ConditionsIntermittent Exotropia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intermittent Exotropia
Sponsor: Nunaps Inc
Enrollment: 54
Locations: 6
Primary Endpoint: Changes in (log) arc second of stereopsis from Baseline to 8 weeks
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 22, 2023

End Date

July 16, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nunaps Inc

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Changes of Stereopsis based on Titmus Symbol Test from baseline to 8 weeks(8 weeks)
Changes of convergence capability score from baseline to 8 weeks(8 weeks)
Changes of Stereopsis based on Distance Randot Stereotest from baseline to 8 weeks(8 weeks)
Changes of strabismus angle from baseline to 8 weeks(8 weeks)
Changes of visuo-motor function from baseline to 8 weeks.(8 weeks)
Proportion of subjects showing improved stereopsis at 8 weeks compared to baseline(8 weeks)