Hyperopia Clinical Trial
Official title:
Enhancement of Emmetropization in Hyperopic Infants
Verified date | October 2012 |
Source | Ohio State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
To determine if wearing a moderate spectacle under-correction (3.00D) and performing activities designed to stimulate accurate accommodation during a 15-month period will enhance emmetropization in highly hyperopic (between +5.00D and +7.00D) 3-month old infants.
Status | Terminated |
Enrollment | 6 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Weeks to 20 Weeks |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University College of Optometry | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University | The Ohio Lions Eye Research Foundation |
United States,
Anker S, Atkinson J, Braddick O, Nardini M, Ehrlich D. Non-cycloplegic refractive screening can identify infants whose visual outcome at 4 years is improved by spectacle correction. Strabismus. 2004 Dec;12(4):227-45. — View Citation
Atkinson J, Anker S, Bobier W, Braddick O, Durden K, Nardini M, Watson P. Normal emmetropization in infants with spectacle correction for hyperopia. Invest Ophthalmol Vis Sci. 2000 Nov;41(12):3726-31. — View Citation
Hung LF, Crawford ML, Smith EL. Spectacle lenses alter eye growth and the refractive status of young monkeys. Nat Med. 1995 Aug;1(8):761-5. — View Citation
Ingram RM, Gill LE, Lambert TW. Effect of spectacles on changes of spherical hypermetropia in infants who did, and did not, have strabismus. Br J Ophthalmol. 2000 Mar;84(3):324-6. — View Citation
Mutti DO, Mitchell GL, Jones LA, Friedman NE, Frane SL, Lin WK, Moeschberger ML, Zadnik K. Axial growth and changes in lenticular and corneal power during emmetropization in infants. Invest Ophthalmol Vis Sci. 2005 Sep;46(9):3074-80. — View Citation
Mutti DO, Mitchell GL, Jones LA, Friedman NE, Frane SL, Lin WK, Moeschberger ML, Zadnik K. Refractive astigmatism and the toricity of ocular components in human infants. Optom Vis Sci. 2004 Oct;81(10):753-61. — View Citation
Schaeffel F, Glasser A, Howland HC. Accommodation, refractive error and eye growth in chickens. Vision Res. 1988;28(5):639-57. — View Citation
Smith EL 3rd, Hung LF. The role of optical defocus in regulating refractive development in infant monkeys. Vision Res. 1999 Apr;39(8):1415-35. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 15 months | No |
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