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

August 12, 2019 updated by: Jay Neitz, University of Washington
  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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: color blocking tint
Spectacles with red-blocking tint subjects will wear glasses daily for 6 months and have
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.
Other: holographic diffuser
Spectacles with color neutral tint subjects will wear glasses daily for 6 months and have
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.
Other: diffuser & color blocking tint
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
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.
Other: holographic diffuser and neutral tint
Spectacles with holographic diffuser and color neutral tint subjects will wear glasses daily for 6 months and have
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every 3 months for 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Seattle Children's Hospital

Investigators

  • Principal Investigator: Jay Neitz, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

August 13, 2013

First Submitted That Met QC Criteria

August 13, 2013

First Posted (Estimate)

August 15, 2013

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCH13693

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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