Trial Comparing Part-time Versus Full-time Patching for Severe Amblyopia
A Randomized Trial Comparing Part-time Versus Full-time Patching for Severe Amblyopia
2 other identifiers
interventional
175
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 full-time patching (all or all but one waking hour) for severe 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
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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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, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 22, 2004
CompletedFirst Posted
Study publicly available on registry
October 25, 2004
CompletedSeptember 9, 2010
September 1, 2010
2.2 years
October 22, 2004
September 8, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Visual acuity improvement at 17wks.
17 weeks
Study Arms (2)
6hrs daily patching
ACTIVE COMPARATOR6 hours per day of patching in the sound eye
Full-time daily patching
ACTIVE COMPARATORPatching of the sound eye all but one waking hour
Interventions
adhesive eye patch used 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 (a refractive error difference of more than one diopter between the two eyes.)
- Visual acuity in the amblyopic eye must be between 20/100 and 20/400.
- 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)
Holmes JM, Kraker RT, Beck RW, Birch EE, Cotter SA, Everett DF, Hertle RW, Quinn GE, Repka MX, Scheiman MM, Wallace DK; Pediatric Eye Disease Investigator Group. A randomized trial of prescribed patching regimens for treatment of severe amblyopia in children. Ophthalmology. 2003 Nov;110(11):2075-87. doi: 10.1016/j.ophtha.2003.08.001.
PMID: 14597512BACKGROUNDRepka 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 22, 2004
First Posted
October 25, 2004
Study Start
May 1, 2001
Primary Completion
July 1, 2003
Study Completion
September 1, 2003
Last Updated
September 9, 2010
Record last verified: 2010-09