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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief Summary:

  1. To determine the effect of spectacles with a red blocking filter on myopia progression in children.
  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. 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.

Detailed Summary:

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:

  1. Color vision tests (Richmond Hardy-Rand-Rittler pseudoisochromatic plate test and/or the Rayleigh match test and/or the Neitz Test of Color Vision), and machine-based vision tests using the Titmus tester (color vision, binocularity, acuity, and heterophoria tests);
  2. each subject will provide a blood sample or a buccal swab for genetic analysis of the long and middle wavelength cone photopigment genes in order to determine the relationship between the cone opsins and myopia;
  3. eye measurements including axial length and corneal curvature will be performed using the Zeiss Intraocular Lens Master;
  4. cycloplegic autorefraction will be doe at the beginning of the study before participants start wearing the study spectacles, after 18 months if wearing the study spectacles, and 6 months after participants stop wearing the study spectacles.

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
Sponsor: University of Washington

Current Primary Outcome: Myopia progression measured by rate of axial elongation of the eye [ Time Frame: every 3 months for 18 months ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Myopia progression measured by cycloplegic autorefraction. [ Time Frame: 18 months ]

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.


Original Secondary Outcome: Same as current

Information By: University of Washington

Dates:
Date Received: August 13, 2013
Date Started: September 2013
Date Completion: December 2017
Last Updated: August 13, 2013
Last Verified: August 2013