Status:
COMPLETED
Bilateral Refractive Amblyopia Treatment Study
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Bilateral Refractive Amblyopia
Eligibility:
All Genders
3-10 years
Brief Summary
The purpose of this study will be to: * Determine the amount of visual acuity improvement with treatment of presumed bilateral refractive amblyopia * Determine the time course of visual acuity improv...
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 cas...
Eligibility Criteria
Inclusion
- Age 3 to \<11 years
- Able to perform single-surrounded single optotype visual acuity using the ATS HOTV protocol for children 3 to \<7 years old and using the E-ETDRS protocol for children 7 to \<11 years old
- Monocular visual acuity in each eye, measured using trial frames or phoropter with best correction derived from cycloplegic refraction, meeting the following criteria:
- Using E-ETDRS testing for patients age 7 to \<11 years: visual acuity 20 to 70 letters (20/40 to 20/400)
- Using ATS HOTV testing for patients age 3 to \<7 years acuity 20/50 to 20/400
- Refractive error that meets at least one of the following criteria in each eye:
- Spherical equivalent \>+4.00 D
- Astigmatism \>2.00 D
- Investigator believes that the patient's reduced visual acuity is due to bilateral, refractive amblyopia
- Investigator not planning to prescribe occlusion, patching or any other amblyopia treatment other than spectacles at this time
- Cycloplegic refraction and ocular examination within 2 months prior to enrollment
Exclusion
- Myopia greater than -6.00 D of spherical power in plus cylinder form
- Ocular cause for decreased acuity in either eye; nystagmus per se will not exclude a patient from the study
- Refractive correction (spectacles or contact lenses) in past three months and no more than one month of refractive correction ever
- Prior treatment for amblyopia (other than the refractive correction permitted in previous exclusion criteria)
- Prior intraocular or refractive surgery
- Use of contact lenses during the study
Key Trial Info
Start Date :
August 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00305955
Start Date
August 1 2004
End Date
October 1 2006
Last Update
March 24 2010
Active Locations (1)
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1
Duke University Eye Center
Durham, North Carolina, United States, 27710