Combined Patching-Atropine for Residual Amblyopia (ATS11)

This study has been terminated.
(Poor enrollment and infeasibility of ever reaching the necessary sample size)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ray Kraker, Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00506675
First received: July 20, 2007
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

This study is designed to evaluate the effectiveness of treatment of residual amblyopia in children ages 3 to < 10 years with visual acuity of 20/32 to 20/63 in the amblyopic eye. The study is a randomized clinical trial comparing intensive treatment (42 hours per week of patching plus daily atropine) with a control group that will have rapid weaning of existing treatment followed by spectacle correction only (if needed). The primary objective is to determine if this intensive treatment will improve visual acuity in patients with residual amblyopia.

The primary outcome assessment is amblyopic eye visual acuity at 10 weeks.

The primary analytic approach for the amblyopic eye acuity will be a treatment group comparison of the proportion of patients with at least two lines of visual acuity improvement.


Condition Intervention Phase
Amblyopia
Device: Patching
Drug: Atropine
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: A Randomized Trial to Evaluate Combined Patching-Atropine for Residual Amblyopia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Distribution of Amblyopic Eye Visual Acuity at 10 Weeks [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
    Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).

  • Mean (SD) Distribution of Visual Acuity at 10 Weeks [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
    Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).

  • Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks [ Time Frame: baseline to 10 Weeks ] [ Designated as safety issue: No ]
    Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.

  • Mean (SD) Change in Visual Acuity in the Amblyopic Eye at the 10 Week Primary Outcome Exam [ Time Frame: baseline to 10 Weeks ] [ Designated as safety issue: No ]
    Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.


Enrollment: 55
Study Start Date: October 2007
Study Completion Date: September 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intensive
42 hours per week of patching combined with atropine (1%) once daily in the sound eye, with spectacle correction (if needed)
Device: Patching
42 hours per week of patching
Other Name: Coverlet, 3M Opticlude, Ortopad®
Drug: Atropine
daily atropine (1%)
Active Comparator: Weaning
For patients currently patching, reduce patching to two hours daily for four weeks, then no treatment thereafter except spectacle correction (if needed). For patients currently using atropine, reduce atropine to once weekly for 4 weeks, then no treatment thereafter except spectacle correction (if needed)
Device: Patching
two hours of daily patching for 4 weeks, then no treatment
Other Name: Coverlet, 3M Opticlude, Ortopad®
Drug: Atropine
once weekly atropine for 4 weeks, then no treatment

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. Despite best efforts with conventional treatment, some patients fail to achieve normal visual acuity in the amblyopic eye. In a randomized trial conducted by PEDIG comparing atropine versus patching in 3 to 6 year olds with moderate amblyopia (ATS1), 261 of 402 patients (65%) had amblyopic eye visual acuity of 20/32 or worse after 6 months of treatment with patching or atropine. Beyond 6 months, treatment was at investigator discretion, and two years after randomization, 181 of 363 children (50%) still had amblyopic eye visual acuity of 20/32 or worse. In a randomized trial conducted by PEDIG comparing patching regimens, 129 of 181 patients with moderate amblyopia (71%) and 145 of 157 patients with severe amblyopia (92%) had amblyopic eye visual acuity of 20/32 or worse after 4 months of occlusion therapy. Many patients receive treatment beyond 6 months but still fail to achieve normal visual acuity in the amblyopic eye. It is unknown whether an intensive "final push" of combined treatment with daily patching and atropine will improve visual acuity in these patients. Although some clinicians prescribe simultaneous patching and atropine for selected patients, there are no published reports of its effectiveness. Also, we are not aware of reports of response to treatment of residual amblyopia.

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. Patients will be randomized to one of two treatment regimens:

  • Intensive treatment: 42 hours per week of patching combined with daily atropine (1%)
  • Control group: Weaning of the current treatment (two hours of daily patching for patients currently using patching and once weekly atropine for patients currently using atropine) for 4 weeks, then no treatment other than spectacles (if needed).
  Eligibility

Ages Eligible for Study:   3 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 3 to < 10 years
  • Amblyopia associated with strabismus, anisometropia, or both
  • Visual acuity in the amblyopic eye between 20/32 and 20/63 inclusive
  • Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >= 2 logMAR lines
  • Current/previous treatment with patching and/or atropine subject to the following stipulations:

    • No simultaneous treatment with patching and atropine in the past 6 months
    • No prior use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D
    • Maximum level of any previous treatment:

      • Patching: up to 42 hours per week (averaging 6 hours daily)
      • Atropine: up to once daily
    • Current treatment with 42 hours per week patching or daily atropine
  • No improvement in best-corrected amblyopic eye visual acuity between two consecutive visits at least 6 weeks apart using the same testing method and optimal spectacle correction (if needed), with no improvement defined as follows:

    • No lines of improvement
    • For patients tested using E-ETDRS, letter score that is no more than 4 letters improved
  • Wearing spectacles with optimal correction (if applicable)
  • Investigator ready to wean or stop treatment

Exclusion Criteria:

  • Current vision therapy or orthoptics
  • Ocular cause for reduced visual acuity
  • Prior intraocular or refractive surgery
  • Strabismus surgery planned within 10 weeks
  • Known allergy to atropine or other cycloplegic drugs
  • Known skin reactions to patch or bandage adhesives
  • Down Syndrome present
  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: NCT00506675

Locations
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 by Jaeb Center for Health Research

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: NCT00506675     History of Changes
Other Study ID Numbers: NEI-135, 2U10EY011751
Study First Received: July 20, 2007
Results First Received: September 14, 2010
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
Patching

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
Atropine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Mydriatics
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014