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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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19 February 2015 |
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Main ID: |
NCT00574717 |
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Date of registration:
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11/12/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Enhancement of Emmetropization in Hyperopic Infants
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Scientific title:
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Enhancement of Emmetropization in Hyperopic Infants |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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6 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00574717 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Donald O. Mutti, OD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Ohio State University College of Optometry |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 3 months of age (between 8 weeks and 20 weeks)at the baseline examination
- Either gender, any ethnicity
- Birthweight greater than 2500g
- Normal pregnancy and delivery (including Cesarean section delivery but excluding
serious complications or conditions such as eclampsia or rubella)
- Hyperopia of +5.00D or more but less than +7.00D spherical equivalent refractive
error in each eye by cycloplegic retinoscopy using cyclopentolate 1%
- Currently under the care of a pediatrician
Exclusion Criteria:
- Anisometropia greater than 1.00D (difference in spherical equivalent)
- Strabismus
- Previous history of difficulty with pupillary dilation
- History of cardiac, liver, asthma, or other respiratory disease
- History of ocular disease or active ocular inflammation
Age minimum:
8 Weeks
Age maximum:
20 Weeks
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Farsightedness
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Hypermetropia
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Hyperopia
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Intervention(s)
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Procedure: Spectacles
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Primary Outcome(s)
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The primary outcome will be to determine if the criterion level for emmetropization (=+3.00D by 18 months of age) is met and maintained by at least 70% of treated infants.
[Time Frame: 15 months]
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Secondary ID(s)
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2004H0157
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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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