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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ray Kraker, Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00315302
First received: April 14, 2006
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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.

Condition Intervention Phase
Amblyopia
Drug: Atropine
Device: Plano Lens
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Jaeb Center for Health Research:

Primary Outcome Measures:
  • Visual Acuity Mean Score in the Amblyopic Eye [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

    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


  • Visual Acuity Distribution in the Amblyopic Eye [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

    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


  • Mean Change in Visual Acuity in the Amblyopic Eye [ Time Frame: baseline to 18 weeks ] [ Designated as safety issue: No ]

    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.


  • Distribution of Change in Visual Acuity in the Amblyopic Eye [ Time Frame: baseline to 18 weeks ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    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.

  • Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    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.

  • Mean Change in Visual Acuity in the Sound Eye [ Time Frame: baseline to 18 weeks ] [ Designated as safety issue: No ]

    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.


  • Distribution of Change in Visual Acuity in the Sound Eye [ Time Frame: baseline to 18 weeks ] [ Designated as safety issue: No ]

    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.


  • Visual Acuity Distribution in the Sound Eye [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

    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



Enrollment: 240
Study Start Date: February 2005
Study Completion Date: January 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atropine
Atropine 1% once each weekend day in the sound eye
Drug: Atropine
Atropine 1% once each weekend day
Other Name: Atropine
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
Other Name: Atropine
Device: Plano Lens
Plano lens for the sound eye

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.

  Eligibility

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00315302

Locations
United States, California
Southern California College of Optometry
Fullerton, California, United States, 92831
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Jaeb Center for Health Research
Investigators
Study Chair: David Weakley, M.D. UT Southwestern Medical Center
Study Chair: Susan A. Cotter, O.D. Southern California College of Optometry
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ray Kraker, Director, PEDIG Coordinating Center, Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00315302     History of Changes
Other Study ID Numbers: NEI-115, 2U10EY011751
Study First Received: April 14, 2006
Results First Received: August 3, 2009
Last Updated: May 16, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Jaeb Center for Health Research:
Amblyopia
Atropine
Plano lens

Additional relevant MeSH terms:
Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Atropine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014