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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 September 2023 |
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Main ID: |
NCT01598818 |
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Date of registration:
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11/05/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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First-Sight Refractive Error Correction in the Developing World
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Scientific title:
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First-Sight Refractive Error Correction in the Developing World |
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Date of first enrolment:
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May 11, 2012 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01598818 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Haiti
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United States
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Contacts
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Name:
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Michael Feilmeier, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Nebraska Medical Center, Department of Ophthalmology and Visual Sciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects must be 7 years of age and older
- Healthy subjects with no known ocular trauma, no surgery, ocular disease or pathology
that would prevent obtainment of best correctable visual acuity to 20/30.
Exclusion Criteria:
- Refractive error greater than (+)/(-) 6.00 diopter, or astigmatism greater than 1.50
diopters.
- Known ocular (corneal, lenticular, vitreal, or retinal) pathology that may limit best
correctable visual acuity.
Age minimum:
7 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Vision Loss
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Primary Outcome(s)
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To compare the best visual acuity and refraction results using the First Sight Refraction System to standard auto-refraction in subjects with hyperopia.
[Time Frame: 1 month]
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Secondary Outcome(s)
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To compare the best visual acuity and refraction results using the First Sight Refractive System to autorefraction in myopia.
[Time Frame: 1 month]
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Secondary ID(s)
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0553-11-FB
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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