Visual Perceptual Learning Based Digital Therapeutics for Stereopsis in Intermittent Exotropia

Nunaps

Status: Completed

Conditions: Intermittent Exotropia

Treatments: Other: No-Treatment Control; Device: Nu.T

Study type: Interventional

Funder types: Industry

Identifiers

NCT06117813

NNS-IXTS-01

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

Nu.T

Experimental group

Description:

Nu.T, 5 times a week for 8 weeks.

Treatment:

Device: Nu.T

No-treatment Control

Other group

Description:

No-treatment was administered during control period.

Treatment:

Other: No-Treatment Control