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| Name | Class |
|---|---|
| Seattle Children's Hospital | OTHER |
In this clinical trial we will determine whether commercially available lens tints that are normally used for cosmetic purposes or for blocking sunlight have a beneficial effect of slowing axial eye growth in children with myopia when used alone or in conjunction with a holographic diffuser that blurs the image slightly.
The following procedures will be performed on a total of 240 children from 8 to 13 years of age:
4) subjects will be randomly assigned to one of four groups, consisting of 60 subjects each, each group will be assigned one of four study spectacles.
The study spectacles for all participants will have the optimal lens corrections for both eyes.
Group 1 participants will wear spectacles with lenses tinted to blocks red light.
Group 2 participants will wear spectacles with lenses that have a holographic diffuser on surface of and that are tinted to reduce the light intensity by the same amount that the red-blocking tint does.
Group 3 participants will wear spectacles that are tinted to block red light and that have a holographic diffuser.
Group 4 participants will wear spectacles that are tinted to reduces the light intensity by the same amount that the red-blocking tint does.
Participants will wear the study glasses for 18 months. Axial length measurements will be taken twice prior to when subjects begin wearing the glasses and once every three month thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| color blocking tint | Experimental | Spectacles with red-blocking tint subjects will wear glasses daily for 6 months and have |
|
| holographic diffuser | Other | Spectacles with color neutral tint subjects will wear glasses daily for 6 months and have |
|
| diffuser & color blocking tint | Other | Spectacles with holographic diffuser and red-blocking tint subjects will wear glasses daily for 6 months and have |
|
| holographic diffuser and neutral tint | Other | Spectacles with holographic diffuser and color neutral tint subjects will wear glasses daily for 6 months and have |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectacles with red-blocking tint | Other | Eyeglasses will have lenses that will correct refractive error for each subject, and will have a tint that blocks red light. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Myopia progression measured by rate of axial elongation of the eye | The axial length of both eyes will be measured before wearing the experimental eyeglasses, then once every three months thereafter for 18 months, and again 6 months after subjects stop wearing the study eye glasses. The rate of axial elongation will be calculated. | every 3 months for 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Myopia progression measured by cycloplegic autorefraction. | A cycloplegic autorefraction will be done at the beginning of the study before subjects start wearing the study glasses, after 18 months of wearing the study glasses,and again about 6 months after wearing the study glasses stopped. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Neitz, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15545808 | Background | Carkeet A, Saw SM, Gazzard G, Tang W, Tan DT. Repeatability of IOLMaster biometry in children. Optom Vis Sci. 2004 Nov;81(11):829-34. doi: 10.1097/01.opx.0000145020.33250.c0. | |
| 14559961 | Background | Congdon NG, Friedman DS, Lietman T. Important causes of visual impairment in the world today. JAMA. 2003 Oct 15;290(15):2057-60. doi: 10.1001/jama.290.15.2057. No abstract available. |
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| Spectacles with holographic diffuser and color neutral tint | Other | Eyeglasses will correct refractive error for each subject but will have a holographic diffuser applied to the surface and will have a color neutral filter to adjust the light intensity reaching the eyes to be the same as for groups 1 and3. |
|
| Spectacles with holographic diffuser and red-blocking tint | Other | Eyeglasses will correct refractive error for each subject and will be tinted to block red light, and will have a holographic diffuser to blur the image. |
|
| Spectacles with color neutral tint | Other | Eyeglasses will correct refractive error for each subject and will have a color neutral tint to adjust the light intensity reaching the eyes so it is the same as for groups 1 and 3. |
|
| 14558848 | Background | Grosvenor T. Why is there an epidemic of myopia? Clin Exp Optom. 2003 Sep;86(5):273-5. doi: 10.1111/j.1444-0938.2003.tb03122.x. No abstract available. |
| 12657584 | Background | Gwiazda J, Hyman L, Hussein M, Everett D, Norton TT, Kurtz D, Leske MC, Manny R, Marsh-Tootle W, Scheiman M. A randomized clinical trial of progressive addition lenses versus single vision lenses on the progression of myopia in children. Invest Ophthalmol Vis Sci. 2003 Apr;44(4):1492-500. doi: 10.1167/iovs.02-0816. |
| 18469186 | Background | Ip JM, Rose KA, Morgan IG, Burlutsky G, Mitchell P. Myopia and the urban environment: findings in a sample of 12-year-old Australian school children. Invest Ophthalmol Vis Sci. 2008 Sep;49(9):3858-63. doi: 10.1167/iovs.07-1451. Epub 2008 May 9. |
| 17159036 | Background | Rein DB, Zhang P, Wirth KE, Lee PP, Hoerger TJ, McCall N, Klein R, Tielsch JM, Vijan S, Saaddine J. The economic burden of major adult visual disorders in the United States. Arch Ophthalmol. 2006 Dec;124(12):1754-60. doi: 10.1001/archopht.124.12.1754. |
| 16101943 | Background | Saw SM, Gazzard G, Shih-Yen EC, Chua WH. Myopia and associated pathological complications. Ophthalmic Physiol Opt. 2005 Sep;25(5):381-91. doi: 10.1111/j.1475-1313.2005.00298.x. |
| 9021311 | Background | Saw SM, Katz J, Schein OD, Chew SJ, Chan TK. Epidemiology of myopia. Epidemiol Rev. 1996;18(2):175-87. doi: 10.1093/oxfordjournals.epirev.a017924. No abstract available. |
| 20008719 | Background | Vitale S, Sperduto RD, Ferris FL 3rd. Increased prevalence of myopia in the United States between 1971-1972 and 1999-2004. Arch Ophthalmol. 2009 Dec;127(12):1632-9. doi: 10.1001/archophthalmol.2009.303. |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| 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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