Comparison of AmblyzTM Glasses and Patching for Amblyopia

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Indiana University
Information provided by (Responsible Party):
Indiana University Identifier:
First received: October 25, 2013
Last updated: February 22, 2016
Last verified: February 2016

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.

Condition Intervention
Device: 4-hour AmblyZ glasses
Device: 12-hour AmblyZ glasses
Device: 2-hour patching
Device: 6-hour patching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of AmblyzTM Glasses and Patching for Amblyopia

Resource links provided by NLM:

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Visual acuity will be assessed at baseline and 12 weeks.

Estimated Enrollment: 116
Study Start Date: November 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   3 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01973348

United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jingyun Wang, PhD    317-944-8103   
Sponsors and Collaborators
Indiana University
  More Information

Responsible Party: Indiana University Identifier: NCT01973348     History of Changes
Other Study ID Numbers: 1307011930 
Study First Received: October 25, 2013
Last Updated: February 22, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Indiana University:

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Eye Diseases
Nervous System Diseases
Neurologic Manifestations
Sensation Disorders
Signs and Symptoms
Vision Disorders
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics processed this record on May 26, 2016