Comparison of AmblyzTM Glasses and Patching for Amblyopia

Electronic eyeglasses, Amblyz™glasses, are a new medical device designed to treat amblyopia, which intermittently become opaque and provide effective occlusion for 50% of the time they are worn. A non-randomized study reported that Amblyz glasses yield an improvement in the amblyopic eye and offer an alternative effective treatment. We are unaware of any randomized clinical trial reports of response to AmblyzTM glasses treatment of amblyopia.

Our hypothesis: Amblyz™glasses can improve visual acuity of the amblyopic eye as effective as traditional patching treatment.

The primary objective is to determine if AmblyzTM equally treats moderate amblyopia as the standard 2-hour patching treatment and AmblyzTM equally treats severe amblyopia as the standard 6-hour patching treatment.

This study is designed to evaluate the effectiveness of a novel amblyopia treatment, AmblyzTM glasses, in treating amblyopia.

Moderate amblyopia: Children ages 3 to <8 years with visual acuity of 20/40 to 20/80 in the amblyopic eye will be enrolled and randomized into two groups: 4-hour AmblyzTM glasses treatment group and standard 2-hour patching control group.

Severe amblyopia: Children ages 3 to <8 years with visual acuity of 20/100 to 20/400 in the amblyopic eye will be enrolled and randomized into two groups: 12-hour AmblyzTM glasses treatment group and standard 6-hour patching control group.

Study Overview

• Status: Terminated
• Conditions: Amblyopia
• Intervention / Treatment: Device: 4-hour AmblyZ glasses; Device: 2-hour patching; Device: 12-hour AmblyZ glasses; Device: 6-hour patching

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Both genders and all races are eligible to this study.
• Age 3 to 8 years
• Amblyopia associated with strabismus, anisometropia, or both
• Visual acuity in the amblyopic eye between 20/40 and 20/80 inclusive
• Visual acuity in the sound eye 20/40 or better and inter-eye acuity difference >3 logarithm of the minimum angle of resolution (logMAR) lines
• Wearing of optimal spectacle correction for a minimum of 4 weeks at the time of enrollment.

Exclusion Criteria:

• No amblyopia treatment before enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4-hour AmblyZ glasses; 4-hour AmblyZ glasses for moderate amblyopia	Device: 4-hour AmblyZ glasses; 4-hour AmblyZ glasses for moderate amblyopia
Active Comparator: 2-hour eye patching; 2-hour eye patching for moderate amblyopia	Device: 2-hour patching; 2-hour patching for moderate amblyopia
Experimental: 12-hour AmblyZ glasses; 12-hour AmblyZ glasses for severe amblyopia	Device: 12-hour AmblyZ glasses; 12-hour AmblyZ glasses for severe amblyopia
Active Comparator: 6-hour eye patching; 6-hour eye patching for severe amblyopia	Device: 6-hour patching; 6-hour patching for severe amblyopia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity Change During 12 Weeks	Visual acuity change during 12 weeks: the difference of visual acuity at baseline and 12 weeks.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reverse Amblyopia	it is defined that the strong eye of the patient decreases two logMAR lines over 3 months.	3 Months
Significant Ocular Deviation Increase From the Baseline	The significant ocular deviation is defined as equal or over 10 degrees of deviation more than that of the baseline.	3 Months

Collaborators and Investigators

• Sponsor: Indiana University

Publications and helpful links

General Publications

• Wang J, Neely DE, Galli J, Schliesser J, Graves A, Damarjian TG, Kovarik J, Bowsher J, Smith HA, Donaldson D, Haider KM, Roberts GJ, Sprunger DT, Plager DA. A pilot randomized clinical trial of intermittent occlusion therapy liquid crystal glasses versus traditional patching for treatment of moderate unilateral amblyopia. J AAPOS. 2016 Aug;20(4):326-31. doi: 10.1016/j.jaapos.2016.05.014. Epub 2016 Jul 12.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: October 25, 2013
• First Posted (Estimate): October 31, 2013

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: amblyopia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Amblyopia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: 1307011930