NCT04784390

Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia

A 16 Week Randomized, Single-masked, Multicenter Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia in Children 4-7 Years of Age With an Open-label Substudy of Binocular Videogames in Children 8-12 Years of Age

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this PoC study was to evaluate the potential therapeutic efficacy of binocular video games played on a tablet and to compare the efficacy of binocular video games versus patching in amblyopic patients 4 to 7 years old (Part A) as well as to gain experience with binocular video games in older children population of 8 to12 years old (Part B). Part A and Part B was designed to provide long term data on durability of binocular video games treatment. The study consisted of two parts, Part A: randomized, single masked PoC study in children 4 to 7 years old at Screening, and Part B: open-label substudy in children 8 to 12 year old at Screening.

Detailed description

The clinical investigation consisted of 2 parts: * Part A: a single-masked, randomized clinical investigation in subjects 4 to 7 years of age. * Part B: an open-label, non-randomized sub-investigation in subjects 8 to 12 years of age. Part A was a 16-week, prospective, randomized, single-masked, multicenter, controlled, 2 arm, parallel-group clinical investigation in subjects 4 to 7 years of age with amblyopia. Subjects were randomly assigned in a 1:1 ratio to either binocular videogame treatment for 8 to 12 weeks or patching treatment for 16 weeks. Randomization was stratified by severity of amblyopia in eligible subjects (moderate amblyopia with best-corrected visual acuity (BCVA) of the amblyopic eye of 20/100 or better, or severe amblyopia with BCVA of the amblyopic eye worse than 20/100). Part B was a 16-week, open-label, single arm sub investigation in subjects 8 to 12 years of age with amblyopia, in which selected sites could participate. Subjects received binocular videogame treatment for 8 weeks, followed by 8 weeks of follow-up.

Conditions

• Amblyopia

Interventions

Type	Name	Description
DEVICE	Binocular video games	Patients will play 1 hour of binocular video game of choice (Dig Rush and/or Monster Burner) a day 7 days a week for 8 to 12 weeks.
DEVICE	Patching of the sound eye	Patients will have their sound eye (fellow eye) patched 2 hours per day 7 days a week for 16 weeks.

Timeline

• Start date: 2021-06-30
• Primary completion: 2022-08-03
• Completion: 2022-08-03
• First posted: 2021-03-05
• Last updated: 2023-05-23

Locations

8 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated device study