MyopiaNCT00335049
Study of Theories About Myopia Progression (STAMP)
A study testing progressive addition spectacle lens (bifocal) and Single Vision Lenses (SVLs) in people with Myopia, run by Ohio State University at 1 site in United States.
Trial summary
At this time, we do not know what causes a child to become more nearsighted (myopic). STAMP will help us better understand nearsightedness in children. Children will be randomly chosen to wear regular glasses (single vision lenses) or no-line bifocal glasses (progressive addition lenses) for the first year of the… Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Myopia
- What is being tested?
- progressive addition spectacle lens (bifocal) and Single Vision Lenses (SVLs)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jul 2010
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6 to 11 years of age
- Best corrected vision of at least 20/30 in each eye
- Birth weight > 1250g
- (The criteria below will be evaluated at a screening visit to find out if the child can participate)
- Accommodative lag >= 1.30 D (for a 4D stimulus)
- At least -0.75 D myopia in each meridian measured with cycloplegic autorefraction but not more than -4.50 D in each meridian in each eye
Show all 9Show fewer
- Esophoria at near if more than -2.25 D spherical equivalent (high myopia)
- Astigmatism < 2.00 DC in each eye
- Anisometropia < 2.00 D
Who cannot join
- Strabismus (eye turn)
- History of contact lens wear
- History of previous bifocal wear
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Optometry
Columbus, Ohio, 43210
About this study
At this time, we do not know what causes a child to become more nearsighted (myopic). STAMP will help us better understand nearsightedness in children. Children will be randomly chosen to wear regular glasses (single vision lenses) or no-line bifocal glasses (progressive addition lenses) for the first year of the study. All children will wear regular glasses for the second year of the study. STAMP will compare how the eye changes shape in the two groups to help us understand why children become nearsighted. The two theories of myopia progression that are being evaluated are based on different factors. One theory is based on environmental factors such as extended near work while the other theory is based on genetically coded factors.
Read the detailed description
Eligible children will be enrolled, randomized, and followed at six-month intervals for two years with all children wearing single vision lenses for the second year. At each visit, complete measurements of the components of the eye will be made to explain the mechanism responsible for the Progressive Addition Lens (PAL) treatment effect and why it occurs mainly during the first year of bifocal wear (Gwiazda et al. 2003). While hyperopic retinal blur (blur at the back of the eye) due to accommodative lag (poor focusing when doing close work) has been proposed as a possible mechanism driving myopia progression (Gwiazda et al. 1993), others have shown that accommodative lag accompanies rather than precedes the onset of myopia (Mutti et al., 2006). This suggests that accommodative lag is a result of another possible mechanism resulting in myopia progression such as crystalline lens-induced ciliary-choroidal tension (a model in which the lens in the eye is stretched and is not as good at focusing up close) (Mutti et al., 2000). According to this proposed mechanism, high accommodative lag in myopia results from increased crystalline lens tension that is transmitted through the choroid (an outside layer of the eye). This tension results in restricted equatorial (the vertical dimension of the eye) eye growth with no axial (front to back) restriction to eye growth and yields a prolate ocular shape (an eye that is longer than it is wide) in myopes (Mutti et al., 2000).
Comparisons: Refractive error (glasses prescription), axial length (length of the eye), peripheral eye shape, accommodation (focusing ability), corneal shape (shape of the front of the eye), anterior chamber depth, crystalline lens thickness and curvatures (shape of the lens in the eye), central and peripheral higher-order aberrations (how well light focuses in the eye), and phoria (eye alignment) will be measured at six-month intervals. The primary study outcome is refractive error measured by cycloplegic autorefraction. Comparison of the biometric data collected both during the first year when the PAL intervention is present and during the second year when the PAL intervention is removed will allow us to differentiate between the two theories under consideration. We will also evaluate whether the modest PAL treatment effect that has been reported during the first year of PAL wear is permanent.
- Conditions
- Myopia
- Being tested
- progressive addition spectacle lens (bifocal), Single Vision Lenses (SVLs)
- Keywords
- myopia progression, bifocal
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive addition spectacle lens (bifocal)Device
Also called PAL
Progressive addition lenses (PAL) with a +2.00 D add.
Single Vision Lenses (SVLs)Device
Also called SVL
Single vision spectacle lenses.
| Study group | Role | What they receive |
|---|---|---|
| PAL | Experimental | Progressive Addition Spectacle Lenses (PALs) with a +2.00 D add worn for first year off study. Single Vision Lenses worn for second year of study. Receives: Device: progressive addition spectacle lens (bifocal) |
| SVL | Active comparator | Single Vision Lenses (SVLs) worn both years of the study. Receives: Device: Single Vision Lenses (SVLs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycloplegic autorefraction
Measured: Baseline, 6, 12, 18, and 24 months
Secondary outcomes (10)
Phoria
Measured: Baseline, 6, 12, 18, and 24 months
Accommodative lag
Measured: Baseline, 6, 12, 18, and 24 months
AC/A ratio
Measured: Baseline, 6, 12, 18, and 24 months
Corneal shape and thickness
Measured: Baseline, 6, 12, 18, and 24 months
Intraocular pressure
Measured: Baseline, 6, 12, 18, and 24 months
Peripheral ocular shape
Measured: Baseline, 6, 12, 18, and 24 months
Central and peripheral aberrations
Measured: Baseline, 6, 12, 18, and 24 months
Crystalline lens thickness and curvature
Measured: Baseline, 6, 12, 18, and 24 months
Anterior chamber depth
Measured: Baseline, 6, 12, 18, and 24 months
Axial length
Measured: Baseline, 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startDec 2006
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Investigators
- David A Berntsen, OD, PhD, Principal investigator, University of HoustonKarla Zadnik, OD, PhD, Principal investigator, Ohio State UniversityDonald O Mutti, OD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335049
- Sponsor's protocol ID
- 2005H0157
- Other IDs
- K12EY015447
- Status last verified
- Oct 2022
- First submitted
- 7 Jun 2006
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gwiazda J, Thorn F, Bauer J, Held R. Myopic children show insufficient accommodative response to blur. Invest Ophthalmol Vis Sci. 1993 Mar;34(3):690-4.
PubMed 8449687Gwiazda 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 12657584Mutti DO, Sholtz RI, Friedman NE, Zadnik K. Peripheral refraction and ocular shape in children. Invest Ophthalmol Vis Sci. 2000 Apr;41(5):1022-30.
PubMed 10752937Mutti DO, Mitchell GL, Hayes JR, Jones LA, Moeschberger ML, Cotter SA, Kleinstein RN, Manny RE, Twelker JD, Zadnik K; CLEERE Study Group. Accommodative lag before and after the onset of myopia. Invest Ophthalmol Vis Sci. 2006 Mar;47(3):837-46. doi: 10.1167/iovs.05-0888.
PubMed 16505015Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.
PubMed 36809645Berntsen DA, Barr CD, Mutti DO, Zadnik K. Peripheral defocus and myopia progression in myopic children randomly assigned to wear single vision and progressive addition lenses. Invest Ophthalmol Vis Sci. 2013 Aug 27;54(8):5761-70. doi: 10.1167/iovs.13-11904.
PubMed 23838771Berntsen DA, Sinnott LT, Mutti DO, Zadnik K. A randomized trial using progressive addition lenses to evaluate theories of myopia progression in children with a high lag of accommodation. Invest Ophthalmol Vis Sci. 2012 Feb 13;53(2):640-9. doi: 10.1167/iovs.11-7769. Print 2012 Feb.
PubMed 22205604Berntsen DA, Mutti DO, Zadnik K. The effect of bifocal add on accommodative lag in myopic children with high accommodative lag. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6104-10. doi: 10.1167/iovs.09-4417. Epub 2010 Aug 4.
PubMed 20688729
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Theories About Myopia Progression (STAMP)
- ClinicalTrials.gov ID
- NCT00335049
- Acronym / sponsor ID
- 2005H0157
- Conditions
- Myopia
- Keywords
- myopia progression, bifocal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Dec 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 8 Jun 2006 (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.
At this time, we do not know what causes a child to become more nearsighted (myopic). STAMP will help us better understand nearsightedness in children. Children will be randomly chosen to wear regular glasses (single vision lenses) or no-line bifocal glasses (progressive addition lenses) for the first year of the study. All children will wear regular glasses for the second year of the study. STAMP will compare how the eye changes shape in the two groups to help us understand why children become nearsighted. The two theories of myopia progression that are being evaluated are based on different factors. One theory is based on environmental factors such as extended near work while the other theory is based on genetically coded factors.
Detailed description
Eligible children will be enrolled, randomized, and followed at six-month intervals for two years with all children wearing single vision lenses for the second year. At each visit, complete measurements of the components of the eye will be made to explain the mechanism responsible for the Progressive Addition Lens (PAL) treatment effect and why it occurs mainly during the first year of bifocal wear (Gwiazda et al. 2003). While hyperopic retinal blur (blur at the back of the eye) due to accommodative lag (poor focusing when doing close work) has been proposed as a possible mechanism driving myopia progression (Gwiazda et al. 1993), others have shown that accommodative lag accompanies rather than precedes the onset of myopia (Mutti et al., 2006). This suggests that accommodative lag is a result of another possible mechanism resulting in myopia progression such as crystalline lens-induced ciliary-choroidal tension (a model in which the lens in the eye is stretched and is not as good at focusing up close) (Mutti et al., 2000). According to this proposed mechanism, high accommodative lag in myopia results from increased crystalline lens tension that is transmitted through the choroid (an outside layer of the eye). This tension results in restricted equatorial (the vertical dimension of the eye) eye growth with no axial (front to back) restriction to eye growth and yields a prolate ocular shape (an eye that is longer than it is wide) in myopes (Mutti et al., 2000).
Comparisons: Refractive error (glasses prescription), axial length (length of the eye), peripheral eye shape, accommodation (focusing ability), corneal shape (shape of the front of the eye), anterior chamber depth, crystalline lens thickness and curvatures (shape of the lens in the eye), central and peripheral higher-order aberrations (how well light focuses in the eye), and phoria (eye alignment) will be measured at six-month intervals. The primary study outcome is refractive error measured by cycloplegic autorefraction. Comparison of the biometric data collected both during the first year when the PAL intervention is present and during the second year when the PAL intervention is removed will allow us to differentiate between the two theories under consideration. We will also evaluate whether the modest PAL treatment effect that has been reported during the first year of PAL wear is permanent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAL | Experimental | Device: progressive addition spectacle lens (bifocal)Progressive Addition Spectacle Lenses (PALs) with a +2.00 D add worn for first year off study. Single Vision Lenses worn for second year of study. |
| SVL | Active comparator | Device: Single Vision Lenses (SVLs)Single Vision Lenses (SVLs) worn both years of the study. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 6 to 11 years of age
- Best corrected vision of at least 20/30 in each eye
- Birth weight > 1250g
- (The criteria below will be evaluated at a screening visit to find out if the child can participate)
- Accommodative lag >= 1.30 D (for a 4D stimulus)
Key exclusion criteria (4 listed)
- Strabismus (eye turn)
- History of contact lens wear
- History of previous bifocal wear
- Diabetes mellitus
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 |
|---|---|---|
| progressive addition spectacle lens (bifocal)Also: PALProgressive addition lenses (PAL) with a +2.00 D add. | Device | PAL |
| Single Vision Lenses (SVLs)Also: SVLSingle vision spectacle lenses. | Device | SVL |
Primary outcome
Cycloplegic autorefraction
Time frame: Baseline, 6, 12, 18, and 24 months
10 secondary outcomes
Phoria
Time frame: Baseline, 6, 12, 18, and 24 months
Accommodative lag
Time frame: Baseline, 6, 12, 18, and 24 months
AC/A ratio
Time frame: Baseline, 6, 12, 18, and 24 months
Corneal shape and thickness
Time frame: Baseline, 6, 12, 18, and 24 months
Intraocular pressure
Time frame: Baseline, 6, 12, 18, and 24 months
Peripheral ocular shape
Time frame: Baseline, 6, 12, 18, and 24 months
Central and peripheral aberrations
Time frame: Baseline, 6, 12, 18, and 24 months
Crystalline lens thickness and curvature
Time frame: Baseline, 6, 12, 18, and 24 months
Anterior chamber depth
Time frame: Baseline, 6, 12, 18, and 24 months
Axial length
Time frame: Baseline, 6, 12, 18, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Background: PubMed 8449687Gwiazda J, Thorn F, Bauer J, Held R. Myopic children show insufficient accommodative response to blur. Invest Ophthalmol Vis Sci. 1993 Mar;34(3):690-4.
- 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 10752937Mutti DO, Sholtz RI, Friedman NE, Zadnik K. Peripheral refraction and ocular shape in children. Invest Ophthalmol Vis Sci. 2000 Apr;41(5):1022-30.
- Background: PubMed 16505015Mutti DO, Mitchell GL, Hayes JR, Jones LA, Moeschberger ML, Cotter SA, Kleinstein RN, Manny RE, Twelker JD, Zadnik K; CLEERE Study Group. Accommodative lag before and after the onset of myopia. Invest Ophthalmol Vis Sci. 2006 Mar;47(3):837-46. doi: 10.1167/iovs.05-0888.
- Derived from this study: PubMed 36809645Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.
- Derived from this study: PubMed 23838771Berntsen DA, Barr CD, Mutti DO, Zadnik K. Peripheral defocus and myopia progression in myopic children randomly assigned to wear single vision and progressive addition lenses. Invest Ophthalmol Vis Sci. 2013 Aug 27;54(8):5761-70. doi: 10.1167/iovs.13-11904.
- Derived from this study: PubMed 22205604Berntsen DA, Sinnott LT, Mutti DO, Zadnik K. A randomized trial using progressive addition lenses to evaluate theories of myopia progression in children with a high lag of accommodation. Invest Ophthalmol Vis Sci. 2012 Feb 13;53(2):640-9. doi: 10.1167/iovs.11-7769. Print 2012 Feb.
- Derived from this study: PubMed 20688729Berntsen DA, Mutti DO, Zadnik K. The effect of bifocal add on accommodative lag in myopic children with high accommodative lag. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6104-10. doi: 10.1167/iovs.09-4417. Epub 2010 Aug 4.
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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.
David A Berntsen, OD, PhD principal investigator
University of Houston
Karla Zadnik, OD, PhD principal investigator
Ohio State University
Donald O Mutti, OD, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progressive addition spectacle lens (bifocal) and Single Vision Lenses (SVLs) in people with Myopia, run by Ohio State University 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 9 inclusion and 4 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: finished, as of the sponsor's last update on 28 Oct 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cycloplegic autorefraction (time frame: Baseline, 6, 12, 18, and 24 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 NCT00335049, which also lists 8 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 28 Oct 2022.