Clinical trial NCT06117813: Visual Perceptual Learning Based Digital Therapeutics for Stereopsis in Intermittent Exotropia
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intermittent Exotropia
Lead sponsor: Nunaps Inc
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 54
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in (log) arc second of stereopsis from Baseline to 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Proportion of subjects showing improved stereopsis at 8 weeks compared to baseline
timeFrame: 8 weeks
measure: Changes of Stereopsis based on Titmus Symbol Test from baseline to 8 weeks
timeFrame: 8 weeks
measure: Changes of Stereopsis based on Distance Randot Stereotest from baseline to 8 weeks
timeFrame: 8 weeks
measure: Changes of strabismus angle from baseline to 8 weeks
timeFrame: 8 weeks
measure: Changes of convergence capability score from baseline to 8 weeks
timeFrame: 8 weeks
measure: Changes of visuo-motor function from baseline to 8 weeks.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Incheon
country: Korea, Republic of
facility: Hangil Eye Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu Eulji Medical Center, Eulji University
Study officials:
affiliation: Asan Medical Center
name: Yeji Moon, MD, PhD
role: STUDY_CHAIR
References: