A New Approach to Vision Therapy Based on Naturalistic 3-D Computer Gaming

NCT03066063 | Completed Results

• 1 other identifier: ICARE2B
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The research team will execute two concurrent studies within a common framework. The first will compare iCare to standard of care occlusion therapy (patching) for amblyopia in patients ages 4 to 18 (inclusive). The second will compare iCare to a standard of care for home-based CI therapy (pencil pushups) for convergence insufficiency patients ages 8 to 18 (inclusive). In the context of this study, the term iCare refers to either the amblyopia or CI video game module as appropriate for the respective study group.

Conditions

Amblyopia; Ocular Motility Disorders

Keywords

Amblyopia; Convergence Insufficiency; Virtual World; Therapy Games

Outcome Measures

Primary Outcomes (2)

• Visual Acuity

  Pre- to post-intervention change in best-corrected vision measured using a logMAR (Logarithm of the Minimum Angle of Resolution) chart, which consists of rows of letters of different sizes. The scale ranges from -0.3 (approximately 20/10 vision on the Snellen chart) to 1 (approximately 20/200 vision). Lower scores indicate better vision.

  Pre- to post-intervention change in best-corrected vision (delta-logMAR) at 12 weeks

• Positive Fusional Vergence (PFV) Base-Out Breakpoint (BOB)

  Cover Testing procedures were followed by evaluation of PFV at near using base-out prisms. A single column of 20/30 letters of the Gulden Fixation stick was advanced towards the subject from the distance of 40cm from the subject's eyes, while the subject continued fusing the letters (keeping them single) while viewing them through a corresponding prism. The magnitude of the prism was increased (for break point) and subsequently decreased (for recovery point) at a rate of about 2∆ /second. The procedure was repeated 3 times and the blinded examiner recorded blur, break and recovery points in prism diopters (∆). Larger numbers are better.

  Pre- to post-intervention change in BOB (delta-BOB) at 12 weeks

Secondary Outcomes (2)

• Near Point of Convergence (NPC) at Break

  Pre- to post-intervention change at 12 weeks

• Convergence Insufficiency Symptom Survey (CISS)

  Pre- to post-intervention change at 12 weeks

Study Arms (4)

Amblyopia standard of care group

ACTIVE COMPARATOR

A standard of care group will be prescribed patching for two or six hours per day, seven days per week. Standard of care group participants with best-corrected vision worse than 20/200 in their amblyopic eye will be prescribed six hours of patching daily, while participants whose best-corrected visual acuity is 20/200 or better will be prescribed two hours of patching daily.

Behavioral: Amblyopia standard of Care

Amblyopia iCare group

EXPERIMENTAL

Participants assigned to an experimental group will play iCare vision therapy games for approximately 20 minutes per day, five days per week.

Device: iCare

Convergence insufficiency standard of care group

ACTIVE COMPARATOR

A standard of care group for convergence insufficiency will perform pencil pushups for 20 minutes per day, five days per week.

Behavioral: CI standard of Care

Convergence insufficiency iCare group

EXPERIMENTAL

The iCare experimental group for convergence insufficiency will be prescribed vision therapy gameplay for approximately 20 minutes per day, five days per week.

Device: iCare

Interventions

iCare DEVICE

The iCare product is an action video game designed to provide home-based vision therapy for non-strabismic amblyopia and convergence insufficiency in children as young as 4 years old. Participants assigned to an iCare group will play iCare vision therapy games for approximately 20 minutes per day, five days per week.

Amblyopia iCare group; Convergence insufficiency iCare group

Amblyopia standard of Care BEHAVIORAL

The amblyopia standard of care group will be prescribed patching for two or six hours per day, seven days per week. Standard of care group participants with best-corrected vision worse than 20/200 in their amblyopic eye will be prescribed six hours of patching daily

Amblyopia standard of care group

CI standard of Care BEHAVIORAL

A dosage-matched CI standard of Care group will be prescribed pencil pushups for 20 minutes per day, five days per week.

Convergence insufficiency standard of care group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 4 to 18 (inclusive);
• Diagnosis of amblyopia associated with anisometropia;
• No amblyopia treatment (atropine, patching, vision therapy) in the past two weeks;
• Spectacles (if required) worn for at least 16 weeks, or demonstrated stability of visual acuity (\< 0.1 logMAR change by the same testing method measured on two exams at least four weeks apart);
• Visual acuity in the amblyopic eye of 20/40 or worse;
• Visual acuity in the fellow eye of 20/25 or better;
• Interocular difference ≥ 0.3 logMAR (3 logMAR chart lines);
• No myopia greater than -6.00D spherical equivalent in either eye;
• Demonstrate in-office ability to play the iCare training game under binocular condition

You may not qualify if:

• Prism in the refractive correction at time of enrollment;
• Previous intraocular or refractive surgery;
• Any treatment for amblyopia in the past two weeks;
• Down syndrome or cerebral palsy or other severe developmental delay that would interfere with treatment or evaluation;
• Heterotropia or heterophoria with a total ocular deviation \> 10∆ at near.
• Best-corrected visual acuity of ≥ 20/25 in each eye at distance and near;
• Exophoria at near at least 4∆ greater than at distance;
• Reduced positive fusional convergence at near (\< 20∆ or fails Sheard's criterion that the PFV measures less than twice the magnitude of the near phoria);
• Near point of convergence of ≥ 6 cm break;
• CI Symptom Survey Score of ≥ 16;
• No use of a plus add for near or base-in prism for at least two weeks preceding enrollment;
• Patient must be wearing appropriate refractive correction for at least two weeks prior to enrollment, if necessary;
• Demonstrate in-office ability to play the iCare training game under binocular conditions.
• ≥ 0.2 logMAR (2 line) difference in best-corrected visual acuity between the two eyes;
• Constant or intermittent exotropia at distance; constant exotropia at near;

Sponsors & Collaborators

• Barron Associates, Inc.: lead
• University of North Dakota: collaborator

Study Sites (1)

Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Conditions

Amblyopia; Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cranial Nerve Diseases

Results Point of Contact

• Title: Richard Adams
• Organization: Barron Associates, Inc.

adams@bainet.com

434-973-1215

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Amblyopia arm enrollees will be randomized to one of two groups. A standard of care group will be prescribed patching for two or six hours per day, seven days per week. Standard of care group participants with best-corrected vision worse than 20/200 in their amblyopic eye will be prescribed six hours of patching daily, while participants whose best-corrected visual acuity is 20/200 or better will be prescribed two hours of patching daily. Participants assigned to an experimental group will play iCare vision therapy games for approximately 20 minutes per day, five days per week. Convergence insufficiency arm enrollees will be assigned to one of two groups: (1) the iCare experimental group, in which participants will be prescribed vision therapy gameplay for approximately 20 minutes per day, five days per week; and (2) a dosage-matched control group, which will be prescribed pencil pushups for 20 minutes per day, five days per week.

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: February 28, 2017
• Study Start: May 7, 2019
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: December 10, 2024
• Results First Posted: December 10, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)