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Lack of funding support for continued recruitment, enrollment, treatment
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| Name | Class |
|---|---|
| The Ohio Lions Eye Research Foundation | UNKNOWN |
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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.
The purpose of the project is to determine if emmetropization can be enhanced in very farsighted babies. We will give them glasses with a partial correction, an amount that is less than their full degree of farsightedness but enough to put them in the zone of effective emmetropization. This 'boost' is meant to enable very farsighted babies to use their eyes in a normal way and emmetropize as normal infants. This partial correction would be given at 3 months of age for a period of up to 15 months. A program of visual engagement is also provided in order to encourage the normal development and use of accommodation. As changes in farsightedness occur, the power of the glasses will be reduced at follow up appointments to keep the farsightedness within the zone of effective emmetropization. Once an infant reaches a normal amount of farsightedness, the glasses would be discontinued.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Infants will receive spectacle under-correction of their hyperopia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectacles | Procedure | Infants will receive spectacles with 3.00D of under-correction relative to the spherical equivalent in each eye as measured by the cycloplegic retinoscopy performed at baseline. They will also receive the full amount of measured astigmatism in their glasses. Changes in spectacle lens power will be made as needed at follow-up visits to keep the level of under-correction within 0.50D of the target 3.00D. A program of visual engagement is also provided to encourage the normal development and use of accommodation. Treatment will continue for 15 months (until 18 months of age) or until the infant reaches a spherical equivalent refractive error of +3.00D or less hyperopia. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald O. Mutti, OD, PhD | The Ohio State University College of Optometry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University College of Optometry | Columbus | Ohio | 43210-1240 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11053269 | Background | 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. | |
| 10684846 | Background | 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. doi: 10.1136/bjo.84.3.324. |
| Label | URL |
|---|---|
| College of Optometry Website | View source |
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| ID | Term |
|---|---|
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| 16123404 | Background | 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. doi: 10.1167/iovs.04-1040. |
| 15557849 | Background | 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. doi: 10.1097/00006324-200410000-00007. |
| 15545141 | Background | 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. doi: 10.1080/09273970490517935. |
| 7585177 | Background | 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. doi: 10.1038/nm0895-761. |
| 3195068 | Background | Schaeffel F, Glasser A, Howland HC. Accommodation, refractive error and eye growth in chickens. Vision Res. 1988;28(5):639-57. doi: 10.1016/0042-6989(88)90113-7. |
| 10343811 | Background | 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. doi: 10.1016/s0042-6989(98)00229-6. |
| Principal Investigator Web Page | View source |