Comparison of AmblyzTM Glasses and Patching for Amblyopia

NCT01973348 | Terminated Results DMC

• 1 other identifier: 1307011930
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amblyopia

Keywords

amblyopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Reverse Amblyopia

  3 Months

• Significant Ocular Deviation Increase From the Baseline

  3 Months

Study Arms (4)

4-hour AmblyZ glasses

EXPERIMENTAL

4-hour AmblyZ glasses for moderate amblyopia

Device: 4-hour AmblyZ glasses

2-hour eye patching

ACTIVE COMPARATOR

2-hour eye patching for moderate amblyopia

Device: 2-hour patching

12-hour AmblyZ glasses

EXPERIMENTAL

12-hour AmblyZ glasses for severe amblyopia

Device: 12-hour AmblyZ glasses

6-hour eye patching

ACTIVE COMPARATOR

6-hour eye patching for severe amblyopia

Device: 6-hour patching

Interventions

4-hour AmblyZ glasses DEVICE

4-hour AmblyZ glasses for moderate amblyopia

4-hour AmblyZ glasses

12-hour AmblyZ glasses DEVICE

12-hour AmblyZ glasses for severe amblyopia

12-hour AmblyZ glasses

2-hour patching DEVICE

2-hour patching for moderate amblyopia

2-hour eye patching

6-hour patching DEVICE

6-hour patching for severe amblyopia

6-hour eye patching

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• No amblyopia treatment before enrollment.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• 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.

  PMID: 27418249 DERIVED

MeSH Terms

Conditions

Amblyopia

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

Limitations and Caveats

1. Sample size is limited; some patients did not come for followup visit. 2. Compliance with treatment is only estimated with calendar log and many patients did not bring back report.

Results Point of Contact

• Title: Dr. Daniel Neely, PI
• Organization: Indiana University

deneely@iupui.edu

3172741214

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: October 31, 2013
• Study Start: November 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 25, 2017
• Results First Posted: July 24, 2017

Record last verified: 2017-07

Locations

US (1)