Visual Perceptual Learning Based Digital Therapeutics for Stereopsis in Intermittent Exotropia
- Conditions
- Intermittent Exotropia
- Interventions
- Device: Nu.TOther: No-Treatment Control
- Registration Number
- NCT06117813
- Lead Sponsor
- Nunaps Inc
- 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 available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 54
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nu.T Nu.T Nu.T, 5 times a week for 8 weeks. No-treatment Control No-Treatment Control No-treatment was administered during control period.
- Primary Outcome Measures
Name Time Method Changes in (log) arc second of stereopsis from Baseline to 8 weeks 8 weeks Stereopsis will be evaluated by a Titmus Dot Test.
- Secondary Outcome Measures
Name Time Method Changes of Stereopsis based on Titmus Symbol Test from baseline to 8 weeks 8 weeks Stereopsis will be evaluated by Titmus Symbol Test.
Changes of convergence capability score from baseline to 8 weeks 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.
Changes of Stereopsis based on Distance Randot Stereotest from baseline to 8 weeks 8 weeks Stereopsis will be evaluated by Distance Randot Stereotest.
Changes of strabismus angle from baseline to 8 weeks 8 weeks Strabismus angle will be evaluated by distance and near-field.
Changes of visuo-motor function from baseline to 8 weeks. 8 weeks Visuo-motor function will be evaluated by the Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2) test.
Proportion of subjects showing improved stereopsis at 8 weeks compared to baseline 8 weeks Improved stereopsis means more than 2 steps increase in Titmus Dot Test.
Trial Locations
- Locations (6)
Inje University Ilsan Paik Hospital
🇰🇷Goyang, Korea, Republic of
Hangil Eye Hospital
🇰🇷Incheon, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Konkuk University Hospital
🇰🇷Seoul, Korea, Republic of
Nowon Eulji Medical Center, Eulji University
🇰🇷Seoul, Korea, Republic of
Uijeongbu Eulji Medical Center, Eulji University
🇰🇷Uijeongbu, Korea, Republic of