MyopiaNCT01923675
Myopia:the Role of Cone Opsin Mutations & Glasses That Control Axial Elongation
A study testing Spectacles with red-blocking tint, Spectacles with holographic diffuser and color neutral tint and Spectacles with holographic diffuser and red-blocking tint in people with Myopia, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Spectacles with red-blocking tint, Spectacles with holographic diffuser and color neutral tint and Spectacles with holographic diffuser and red-blocking tint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- glaucoma, amblyopia, strabismus
- ocular disease
- developmental delay
- history of wearing bifocal lenses
- any type of eye surgery
- color vision deficiency
Trial locations and contacts
1 site in 1 country.
About this study
- To determine the effect of spectacles with a red blocking filter on myopia progression in children.
- 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
- 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.
Read the 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:
- 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);
- 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;
- eye measurements including axial length and corneal curvature will be performed using the Zeiss Intraocular Lens Master;
- 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.
- 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.
- Conditions
- Myopia
- Being tested
- Spectacles with red-blocking tint, Spectacles with holographic diffuser and color neutral tint, Spectacles with holographic diffuser and red-blocking tint, Spectacles with color neutral tint
- Keywords
- myopia, nearsightedness, axial elongation of the eye, refractive error
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectacles with red-blocking tintOther
Eyeglasses will have lenses that will correct refractive error for each subject, and will have a tint that blocks red light.
Spectacles with holographic diffuser and color neutral tintOther
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 tintOther
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 tintOther
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.
| Study group | Role | What they receive |
|---|---|---|
| color blocking tint | Experimental | Spectacles with red-blocking tint subjects will wear glasses daily for 6 months and have Receives: Other: Spectacles with red-blocking tint |
| holographic diffuser | Other | Spectacles with color neutral tint subjects will wear glasses daily for 6 months and have Receives: 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 Receives: 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 Receives: Other: Spectacles with color neutral tint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: every 3 months for 18 months
Secondary outcomes (1)
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study startNov 2013 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Children's Hospital
- Responsible party
- Principal investigator, Jay Neitz, University of Washington
- Investigators
- Jay Neitz, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923675
- Sponsor's protocol ID
- SCH13693
- Status last verified
- Aug 2019
- First submitted
- 13 Aug 2013
- Last updated
- 14 Aug 2019
- Results posted
- No
Publications
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.
PubMed 15545808Congdon 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.
PubMed 14559961Grosvenor 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.
PubMed 14558848Gwiazda 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.
PubMed 12657584Ip 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.
PubMed 18469186Rein 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.
PubMed 17159036Saw 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.
PubMed 16101943Saw 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.
PubMed 9021311Vitale 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.
PubMed 20008719
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myopia:the Role of Cone Opsin Mutations & Glasses That Control Axial Elongation
- ClinicalTrials.gov ID
- NCT01923675
- Acronym / sponsor ID
- SCH13693
- Conditions
- Myopia
- Keywords
- myopia, nearsightedness, axial elongation of the eye, refractive error
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Seattle Children's Hospital
- Study start
- Nov 2013 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To determine the effect of spectacles with a red blocking filter on myopia progression in children.
- 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
- 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 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:
- 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);
- 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;
- eye measurements including axial length and corneal curvature will be performed using the Zeiss Intraocular Lens Master;
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| color blocking tint | Experimental | Other: Spectacles with red-blocking tintSpectacles with red-blocking tint subjects will wear glasses daily for 6 months and have |
| holographic diffuser | Other | Other: Spectacles with holographic diffuser and color neutral tintSpectacles with color neutral tint subjects will wear glasses daily for 6 months and have |
| diffuser & color blocking tint | Other | Other: Spectacles with holographic diffuser and red-blocking tintSpectacles with holographic diffuser and red-blocking tint subjects will wear glasses daily for 6 months and have |
| holographic diffuser and neutral tint | Other | Other: Spectacles with color neutral tintSpectacles with holographic diffuser and color neutral tint subjects will wear glasses daily for 6 months and have |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- glaucoma, amblyopia, strabismus
- ocular disease
- developmental delay
- history of wearing bifocal lenses
- any type of eye surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectacles with red-blocking tintEyeglasses will have lenses that will correct refractive error for each subject, and will have a tint that blocks red light. | Other | color blocking tint |
| Spectacles with holographic diffuser and color neutral tintEyeglasses 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 | holographic diffuser |
| Spectacles with holographic diffuser and red-blocking tintEyeglasses 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 | diffuser & color blocking tint |
| Spectacles with color neutral tintEyeglasses 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. | Other | holographic diffuser and neutral tint |
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.
1 secondary outcome
Myopia progression measured by cycloplegic autorefraction.
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Background: PubMed 15545808Carkeet 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.
- Background: PubMed 14559961Congdon 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.
- Background: PubMed 14558848Grosvenor 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.
- Background: PubMed 12657584Gwiazda 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.
- Background: PubMed 18469186Ip 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.
- Background: PubMed 17159036Rein 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.
- Background: PubMed 16101943Saw 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.
- Background: PubMed 9021311Saw 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.
- Background: PubMed 20008719Vitale 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Neitz, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectacles with red-blocking tint, Spectacles with holographic diffuser and color neutral tint and Spectacles with holographic diffuser and red-blocking tint in people with Myopia, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myopia progression measured by rate of axial elongation of the eye (time frame: every 3 months for 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01923675, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.