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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by University of Washington
Sponsor:
Collaborator:
Seattle Children's Hospital
Information provided by (Responsible Party):
Jay Neitz, University of Washington
ClinicalTrials.gov Identifier:
NCT01923675
First received: August 13, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  Purpose
  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.

Condition Intervention
Myopia
Other: Spectacles with red-blocking tint
Other: Spectacles with holographic diffuser and color neutral tint
Other: Spectacles with holographic diffuser and red-blocking tint
Other: Spectacles with color neutral tint

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Myopia:the Role of Cone Opsin Mutations & Glasses That Control Axial Elongation

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Myopia progression measured by rate of axial elongation of the eye [ Time Frame: every 3 months for 18 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Myopia progression measured by cycloplegic autorefraction. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 240
Study Start Date: September 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 block red light
Spectacles with red-blocking tint.
Other: Spectacles with red-blocking tint
Eyeglasses will have lenses that will correct refractive error for each subject, and will have a tint that blocks red light.
Experimental: Group 2 blur image
Spectacles with holographic diffuser and color neutral tint
Other: Spectacles with holographic diffuser and color neutral tint
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.
Experimental: Group 3 blur image and block red light
Spectacles with holographic diffuser and red-blocking tint.
Other: Spectacles with holographic diffuser and red-blocking tint
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.
Group 4 neutral tint
Spectacles with color neutral tint
Other: Spectacles with color neutral tint
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.

Detailed Description:

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 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.

  Eligibility

Ages Eligible for Study:   8 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • glaucoma, amblyopia, strabismus
  • ocular disease
  • developmental delay
  • history of wearing bifocal lenses
  • any type of eye surgery
  • color vision deficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01923675

Contacts
Contact: Jay Neitz, PhD 206 543 8065 jneitz@uw.edu
Contact: Maureen Neitz, PhD 206 543 7998 mneitz@uw.edu

Locations
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Jay Neitz, PhD    206-543-8065    jneitz@uw.edu   
Contact: Maureen Neitz, PhD    206 543 7988    mneitz@uw.edu   
Principal Investigator: Jay Neitz, PhD         
Sub-Investigator: Maureen Neitz, PhD         
Sponsors and Collaborators
University of Washington
Seattle Children's Hospital
Investigators
Principal Investigator: Jay Neitz, PhD University of Washington
  More Information

Publications:

Responsible Party: Jay Neitz, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01923675     History of Changes
Other Study ID Numbers: R01EY0021242
Study First Received: August 13, 2013
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
myopia
nearsightedness
axial elongation of the eye
refractive error

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 24, 2014