Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old (ATS16)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00944710
First received: July 21, 2009
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but amblyopia is still present. Children ages 3 to <8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with weekend atropine until no improvement, followed by randomization of eligible patients to weekend atropine treatment with a plano lens over the sound eye versus without a plano lens over the sound eye. The primary objective is to determine if adding a plano lens to weekend atropine will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Amblyopic eye visual acuity [ Time Frame: 10 weeks after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sound eye visual acuity [ Time Frame: 12 weeks after randomization ] [ Designated as safety issue: Yes ]
  • Differences between treatment groups in stereoacuity [ Time Frame: 12 weeks after randomization ] [ Designated as safety issue: Yes ]
  • Ocular alignment [ Time Frame: 12 weeks after randomization ] [ Designated as safety issue: Yes ]
  • Treatment group comparison of the proportion of patients who have improved by 2 or more logMAR visual acuity lines [ Time Frame: 10 weeks after randomization ] [ Designated as safety issue: No ]
  • Patients in both groups who have improved by 1 or more lines from baseline to the 10-week outcome exam will have a treatment group comparison of the proportion of patients with at least 2 logMAR lines of visual acuity improvement [ Time Frame: Last study visit ] [ Designated as safety issue: No ]
  • Patients in both groups who have improved by 1 or more lines from baseline to the 10-week outcome exam will have a treatment group comparison of logMAR visual acuity scores in the amblyopic eye [ Time Frame: Last study visit ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: August 2009
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intensified treatment
Weekend atropine 1% with plano lens over the sound eye
Drug: Atropine
Weekend atropine 1%
Other Name: Atropine
Device: Plano lens
plano lens over the sound eye
Active Comparator: Control
Weekend atropine 1%
Drug: Atropine
Weekend atropine 1%
Other Name: Atropine

Detailed Description:

Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children.1 Many practitioners prescribe weekend atropine as initial therapy for amblyopia. However, many children fail to achieve normal visual acuity in the amblyopic eye after treatment with this regimen. In a randomized trial conducted by PEDIG comparing atropine regimens, 58 of 83 patients with moderate amblyopia (70%) had amblyopic eye visual acuity of 20/32 or worse after 4 months of treatment with weekend atropine.2 In another PEDIG randomized trial comparing atropine with a plano lens versus without a plano lens for initial treatment of amblyopia, 60 of 84 patients with moderate amblyopia (71%) had amblyopic eye visual acuity of 20/32 or worse after 16 weeks of treatment with weekend atropine.3 When improvement stops after initial therapy and amblyopia is still present, treatment options include increasing the dosage of current treatment, switching to another treatment, maintaining the same treatment and dosage, or combining treatments. Many clinicians will add a plano lens over the sound eye to atropine treatment, in part because families using atropine have become comfortable with its use. This option is limited to children with hypermetropia in the sound eye. However, it is unknown whether adding a plano lens over the sound eye will improve amblyopic eye visual acuity more than continuing atropine alone in patients who have shown no improvement after initial treatment with atropine. In a PEDIG randomized trial comparing patching to atropine for initial treatment of amblyopia, a plano lens was prescribed for the sound eye for 55 patients who had not improved to 20/30 or at least 3 lines after 4 months of daily atropine use.1, 4 Their mean acuity improvement prior to using the plano lens was 1.0 line, compared with 1.6 lines after prescribing the plano lens. We are unaware of any reports of the response of treatment of amblyopia still present after initial treatment with weekend atropine.

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Major Eligibility Criteria for Run-in Phase

  • Age 3 to < 8 years
  • Amblyopia associated with strabismus, anisometropia, or both
  • Visual acuity in the amblyopic eye between 20/50 and 20/400 inclusive
  • Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >3 logMAR lines
  • Amblyopia treatment within the past 6 months subject to the following stipulations:

    • No more than 6 weeks of any amblyopia treatment other than spectacles (except for patients being treated with atropine who are entering the study on treatment)
    • No simultaneous treatment with patching and atropine
    • No use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D
    • Maximum level of treatment within the past 6 months:

      • Patching: up to 2 hours daily
      • Atropine: up to once daily
  • Wearing spectacles with optimal correction (if amblyopic eye acuity is 20/80 or better, then VA must be stable in glasses; if amblyopic eye acuity is 20/100 or worse, then spectacles and atropine can be initiated simultaneously).
  • Hypermetropia and spectacle correction in sound eye of +1.50 D or more

Eligibility Criteria for Randomization:

  • Amblyopic eye acuity of 20/40 to 20/160 with an inter-ocular difference of >2 lines, or amblyopic eye acuity of 20/32 with 3 lines of IOD.
  • Compliance with weekend atropine treatment based on investigator judgment.

Exclusion Criteria:

  • Currently using vision therapy or orthoptics
  • Ocular cause for reduced visual acuity (nystagmus per se does not exclude the patient if the above visual acuity criteria are met)
  • Prior intraocular or refractive surgery
  • Known allergy to atropine or other cycloplegic drugs
  • Down Syndrome present
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944710

Locations
United States, California
Southern California College of Optometry
Fullerton, California, United States, 92831
United States, North Carolina
Duke University Eye Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Jaeb Center for Health Research
Investigators
Study Chair: David K. Wallace, M.D. Duke University Eye Center
  More Information

No publications provided

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00944710     History of Changes
Other Study ID Numbers: NEI-144, 2U10EY011751
Study First Received: July 21, 2009
Last Updated: November 19, 2013
Health Authority: 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 April 16, 2014