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Tracking Information | |||||
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First Received Date † | March 20, 2006 | ||||
Last Updated Date | November 13, 2007 | ||||
Start Date † | August 2004 | ||||
Current Primary Outcome Measures † |
Visual acuity of 20/25 or better in both eyes | ||||
Original Primary Outcome Measures † |
Visual acuity of 20/25 or better in both eyes | ||||
Change History | Complete list of historical versions of study NCT00305955 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Bilateral Refractive Amblyopia Treatment Study | ||||
Official Title † | Bilateral Refractive Amblyopia Treatment Study | ||||
Brief Summary | The purpose of this study will be to:
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Detailed Description | There is a paucity of literature on bilateral amblyopia that is due to a substantial amount of refractive error (hypermetropia or astigmatism), and it is limited principally to review articles and case reports. The incidence is not known, but in one study, 4 of 830 (0.5%) children examined at the time of entry into school had bilateral amblyopia. Schoenleber et al performed a retrospective review of office records and identified 184 children with >
Sample size: The study plans to enroll 100 patients. At least 50 patients will be enrolled who have an interocular difference of less than 3 lines by ATS HOTV or less than 15 letters by E-ETDRS at the Spectacle Baseline visit. |
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Study Phase | Phase III | ||||
Study Type † | Observational | ||||
Study Design † | Prospective | ||||
Condition † | Bilateral Refractive Amblyopia | ||||
Intervention † | Device: Spectacles | ||||
Study Arms / Comparison Groups | |||||
Publications * | Wallace DK, Chandler DL, Beck RW, Arnold RW, Bacal DA, Birch EE, Felius J, Frazier M, Holmes JM, Hoover D, Klimek DA, Lorenzana I, Quinn GE, Repka MX, Suh DW, Tamkins S; Pediatric Eye Disease Investigator Group. Treatment of bilateral refractive amblyopia in children three to less than 10 years of age. Am J Ophthalmol. 2007 Oct;144(4):487-96. Epub 2007 Aug 20. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 113 | ||||
Completion Date | July 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 3 Years to 10 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00305955 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | National Eye Institute (NEI) | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Eye Institute (NEI) | ||||
Verification Date | November 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |