Visual Perceptual Learning Based Digital Therapeutics for Stereopsis in Intermittent Exotropia

Intermittent Exotropia Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117813
• Other study ID #: NNS-IXTS-01
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: Nunaps Inc
• Contact: Dong-Wha Kang, MD, PhD
• Phone: +82-2-488-6542
• Email: dwk[@]nunaps.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Exotropia
• Intermittent Exotropia

Intervention

Device:
• Nu.T
Participants receive visual perceptual training using the Nu.T software.

Other:
• No-Treatment Control
No-treatment was administered during control period.

Locations

Country	Name	City	State
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Konkuk University Hospital	Seoul
Korea, Republic of	Nowon Eulji Medical Center, Eulji University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Nunaps Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in (log) arc second of stereopsis from Baseline to 8 weeks	Stereopsis will be evaluated by a Titmus Dot Test.	8 weeks
Secondary	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
Secondary	Changes of Stereopsis based on Titmus Symbol Test from baseline to 8 weeks	Stereopsis will be evaluated by Titmus Symbol Test.	8 weeks
Secondary	Changes of Stereopsis based on Distance Randot Stereotest from baseline to 8 weeks	Stereopsis will be evaluated by Distance Randot Stereotest.	8 weeks
Secondary	Changes of strabismus angle from baseline to 8 weeks	Strabismus angle will be evaluated by distance and near-field.	8 weeks
Secondary	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
Secondary	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