Myopia:the Role of Cone Opsin Mutations & Glasses That Control Axial Elongation

NCT01923675 | Withdrawn

• 1 other identifier: SCH13693
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To determine the effect of spectacles with a red blocking filter on myopia progression in children.
2. 2.To determine the effect of spectacles with a holographic diffuser that spreads incident light rays over an angle of 0.5 degrees on myopia progression in children
3. 3.To determine the combined effects of spectacles with a red blocking filter and a diffuser that spreads incident light over an angle of 0.5 degrees on myopia progression in children.

Conditions

Myopia

Keywords

myopia; nearsightedness; axial elongation of the eye; refractive error

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Myopia progression measured by cycloplegic autorefraction.

  18 months

Study Arms (4)

color blocking tint

EXPERIMENTAL

Spectacles with red-blocking tint subjects will wear glasses daily for 6 months and have

Other: Spectacles with red-blocking tint

holographic diffuser

OTHER

Spectacles with color neutral tint subjects will wear glasses daily for 6 months and have

Other: Spectacles with holographic diffuser and color neutral tint

diffuser & color blocking tint

OTHER

Spectacles with holographic diffuser and red-blocking tint subjects will wear glasses daily for 6 months and have

Other: Spectacles with holographic diffuser and red-blocking tint

holographic diffuser and neutral tint

OTHER

Spectacles with holographic diffuser and color neutral tint subjects will wear glasses daily for 6 months and have

Other: Spectacles with color neutral tint

Interventions

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.

color blocking tint

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.

holographic diffuser

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.

diffuser & color blocking tint

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.

holographic diffuser and neutral tint

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• nearsighted having a refractive error of at least -0.5 diopters
• myopia progression at least -.50 D per year in previous year
• astigmatism and anisometropia not more than 1.5 D
• distance monocular acuity 6/6 or better
• near monocular acuity of 0.4 M or better
• stereoacuity not more than 40 sec of arc at 40 cm
• able to respond to subjective testing
• no contact lens use during the study
• able to comply with wearing the experimental lenses daily for 18 months
• able to have axial length measurements accurately on the Zeiss Intraocular Lens Master
• willing to donate a blood sample or a buccal swab for genetic analysis
• can be refracted to 20/20 or 20/15

You may not qualify if:

• glaucoma, amblyopia, strabismus
• ocular disease
• developmental delay
• history of wearing bifocal lenses
• any type of eye surgery
• color vision deficiency

Sponsors & Collaborators

• University of Washington: lead
• Seattle Children's Hospital: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98109, United States

Location

Related Publications (9)

• 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.

  PMID: 15545808 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.

  PMID: 14559961 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.

  PMID: 14558848 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.

  PMID: 12657584 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.

  PMID: 18469186 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.

  PMID: 17159036 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.

  PMID: 16101943 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.

  PMID: 9021311 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.

  PMID: 20008719 BACKGROUND

MeSH Terms

Conditions

Myopia; Refractive Errors

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Jay Neitz, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 15, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

US (1)