Trial Comparing Part-time Versus Minimal-time Patching for Moderate Amblyopia
ATS2B
A Randomized Trial Comparing Part-time Versus Minimal-time Patching for Moderate Amblyopia
2 other identifiers
interventional
189
1 country
1
Brief Summary
The goals of this study are:
- To determine whether the visual acuity improvement obtained with part-time (6 hours) patching is equivalent to the visual acuity improvement obtained with minimal patching (2 hours) for moderate amblyopia.
- To develop more precise estimates than currently available for the visual acuity improvement that occurs during treatment of amblyopia with patching.
- To identify factors that may be associated with successful treatment of amblyopia with patching.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2001
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 21, 2004
CompletedFirst Posted
Study publicly available on registry
October 22, 2004
CompletedSeptember 9, 2010
September 1, 2010
1.2 years
October 21, 2004
September 8, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Visual acuity improvement
17 weeks
Study Arms (2)
2hrs daily patching
ACTIVE COMPARATOR2 hours patching per day to cover the sound eye
6hrs daily patching
ACTIVE COMPARATOR6 hours per day patching to cover the sound eye
Interventions
adhesive patch to cover the sound eye
Eligibility Criteria
You may qualify if:
- Patients must be less than 7 years of age with the original cause of amblyopia as strabismus or anisometropia.
- Visual Acuity in the amblyopic eye must be between 20/40 and 20/80.
- Visual acuity in the sound eye of 20/40 or better.
- There must be at least 3 lines of acuity difference between the two eyes.
You may not qualify if:
- Patching treatment (other than spectacles) within six months prior to enrollment and other amblyopia treatment of any type used within one month prior to enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jaeb Center for Health Researchlead
- National Eye Institute (NEI)collaborator
Study Sites (1)
Wilmer Eye Institute
Baltimore, Maryland, 21287-9028, United States
Related Publications (2)
Repka MX, Beck RW, Holmes JM, Birch EE, Chandler DL, Cotter SA, Hertle RW, Kraker RT, Moke PS, Quinn GE, Scheiman MM; Pediatric Eye Disease Investigator Group. A randomized trial of patching regimens for treatment of moderate amblyopia in children. Arch Ophthalmol. 2003 May;121(5):603-11. doi: 10.1001/archopht.121.5.603.
PMID: 12742836BACKGROUNDRepka M, Simons K, Kraker R; Pediatric Eye Disease Investigator Group. Laterality of amblyopia. Am J Ophthalmol. 2010 Aug;150(2):270-4. doi: 10.1016/j.ajo.2010.01.040. Epub 2010 May 8.
PMID: 20451898DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael X Repka, M.D.
Wilmer Eye Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 21, 2004
First Posted
October 22, 2004
Study Start
May 1, 2001
Primary Completion
July 1, 2002
Study Completion
September 1, 2002
Last Updated
September 9, 2010
Record last verified: 2010-09