Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old (ATS8)

July 15, 2016 updated by: Ray Kraker, Jaeb Center for Health Research

A Randomized Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye As Prescribed Treatments for Amblyopia in Children 3 to <7 Years Old

The purpose of the study is:

  • To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old.
  • To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Atropine is an effective treatment of moderate amblyopia. Reduction of the plus sphere for the sound eye is an accepted method of enhancing and possibly accelerating the treatment effect. Demonstrating additional value of the plano lens in terms of speed of improvement will shorten the treatment period, possibly improving child and parental compliance, leading to improved overall outcomes for patients with amblyopia. If the plano lens leads to greater improvement, then there will be less permanent visual impairment in patients with a history of amblyopia. It also is important to determine if the use of a plano lens in conjunction with atropine has a deleterious effect on the sound eye, and if yes, how often this occurs.

Little is known about the pharmacologic treatment of severe amblyopia. This study will provide important prospectively determined outcome data at little additional expense.

In a study conducted by the Pediatric Eye Disease Investigator Group, A Randomized Trial Comparing Daily Atropine Versus Weekend Atropine for Moderate Amblyopia, the use of weekend atropine for moderate amblyopia was as effective as daily treatment. Intermittent atropine use (such as using it only on the weekends) has the theoretical potential benefit of the sound eye having some time each week during which cycloplegia is only partial. It is possible that allowing some loss of the cycloplegic effect over the course of each week may be safer for the sound eye.

The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. The two treatment regimes for the 18 week primary treatment period are: 1) Atropine 1% once each weekend day in the sound eye and 2) Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fullerton, California, United States, 92831
        • Southern California College of Optometry
    • Texas
      • Dallas, Texas, United States, 75235
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must be 3 to less than 7 years old with amblyopia associated with strabismus, anisometropia, or both.
  • Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference > 3 logMAR lines.
  • Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.

Exclusion Criteria:

  • Atropine treatment within 6 months of enrollment and other amblyopia treatment of any type (other than normal spectacle lenses) used within one month of enrollment
  • No myopia in amblyopic eye

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Atropine
Atropine 1% once each weekend day in the sound eye
Drug: Atropine
Atropine 1% once each weekend day
Active Comparator: Atropine plus plano
Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye
Drug: Atropine
Atropine 1% once each weekend day
Device: Plano Lens
Plano lens for the sound eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity Mean Score in the Amblyopic Eye
Time Frame: 18 weeks

Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in an Snellen equivalent acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.

20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst
18 weeks
Visual Acuity Distribution in the Amblyopic Eye
Time Frame: 18 weeks

Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.

20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst
18 weeks
Mean Change in Visual Acuity in the Amblyopic Eye
Time Frame: baseline to 18 weeks

Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.

A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.
baseline to 18 weeks
Distribution of Change in Visual Acuity in the Amblyopic Eye
Time Frame: baseline to 18 weeks

Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.

A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.
baseline to 18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia
Time Frame: 18 weeks
The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
18 weeks
Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only
Time Frame: 18 weeks
The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
18 weeks
Mean Change in Visual Acuity in the Sound Eye
Time Frame: baseline to 18 weeks

Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.

A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.
baseline to 18 weeks
Distribution of Change in Visual Acuity in the Sound Eye
Time Frame: baseline to 18 weeks

Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.

A positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.
baseline to 18 weeks
Visual Acuity Distribution in the Sound Eye
Time Frame: 18 weeks

Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18 wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.

20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaeb Center for Health Research

Collaborators

National Eye Institute (NEI)

Investigators

  • Study Chair: David Weakley, M.D., UT Southwestern Medical Center
  • Study Chair: Susan A. Cotter, O.D., Southern California College of Optometry at Marshall B. Ketchum University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

April 14, 2006

First Submitted That Met QC Criteria

April 14, 2006

First Posted (Estimate)

April 18, 2006

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEI-115
  • 2U10EY011751 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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