Comparison of AmblyzTM Glasses and Patching for Amblyopia

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01973348
First received: October 25, 2013
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

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 amblyopia as the standard 2-hour patching amblyopia treatment. This study is designed to evaluate the effectiveness of a novel amblyopia treatment, AmblyzTM glasses, in treating 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.


Condition Intervention
Amblyopia
Device: AmblyZ glasses
Device: eye patch

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: 40
Study Start Date: November 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AmblyZ glasses
4-hour AmblyZ glasses
Device: AmblyZ glasses
Active Comparator: eye patching
2-hour eye patching
Device: eye patch

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01973348

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

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01973348     History of Changes
Other Study ID Numbers: 1307011930
Study First Received: October 25, 2013
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Indiana University:
amblyopia

Additional relevant MeSH terms:
Amblyopia
Brain Diseases
Central Nervous System Diseases
Eye Diseases
Nervous System Diseases
Neurologic Manifestations
Sensation Disorders
Signs and Symptoms
Vision Disorders

ClinicalTrials.gov processed this record on October 23, 2014