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| Sponsored by: |
National Eye Institute (NEI) |
|---|---|
| Information provided by: | National Eye Institute (NEI) |
| ClinicalTrials.gov Identifier: | NCT00506675 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized Trial to Evaluate Combined Patching-Atropine for Residual Amblyopia |
| Estimated Enrollment: | 240 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Intensive: Active Comparator
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
Drug: Atropine
daily atropine (1%)
|
|
Weaning: Active Comparator
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
Drug: Atropine
once weekly atropine for 4 weeks, then no treatment
|
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:
Eligibility| Ages Eligible for Study: | 3 Years to 9 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Current/previous treatment with patching and/or atropine subject to the following stipulations:
Maximum level of any previous treatment:
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:
Exclusion Criteria:
Contacts and Locations| Contact: Raymond T. Kraker, M.S.P.H. | 813-975-8690 | pedig@jaeb.org |
| Contact: Heidi A. Gillespie | 813-975-8690 | pedig@jaeb.org |
| United States, North Carolina | |
| Duke University Eye Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: David K. Wallace, M.D., M.P.H. 919-684-4584 | |
| Principal Investigator: David K. Wallace, M.D., M.P.H. | |
| Study Chair: | David K. Wallace, M.D. | Duke University Eye Center |
More Information
| Responsible Party: | Jaeb Center for Health Research ( Roy W. Beck, M.D., Ph.D., Executive Director ) |
| Study ID Numbers: | NEI-135 |
| Study First Received: | July 20, 2007 |
| Last Updated: | October 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00506675 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
Amblyopia Atropine Patching |
|
Signs and Symptoms Sensation Disorders Vision Disorders Amblyopia Eye Diseases |
Neurologic Manifestations Central Nervous System Diseases Brain Diseases Atropine |
|
Parasympatholytics Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Nervous System Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Cardiovascular Agents Cholinergic Agents |
Pharmacologic Actions Muscarinic Antagonists Adjuvants, Anesthesia Mydriatics Autonomic Agents Therapeutic Uses Anti-Arrhythmia Agents Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents |
