HyperopiaPhase 1/2NCT00574717
Enhancement of Emmetropization in Hyperopic Infants
A Phase 1/2 study testing Spectacles in people with Hyperopia and Hypermetropia, run by Ohio State University at 1 site in United States.
Trial summary
To determine if wearing a moderate spectacle under-correction (3.00D) and performing activities designed to stimulate accurate accommodation during a 15-month period will enhance emmetropization in highly hyperopic (between +5.00D and +7.00D) 3-month old infants. Read more about this study
- Who is it for?
- Ages 8 to 20 weeks
- Conditions the study is for
- Hyperopia, Hypermetropia, Farsightedness
- What is being tested?
- Spectacles
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Sep 2010
- Phase
- Phase 1/2
- 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 20 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3 months of age (between 8 weeks and 20 weeks)at the baseline examination
- Either gender, any ethnicity
- Birthweight greater than 2500g
- Normal pregnancy and delivery (including Cesarean section delivery but excluding serious complications or conditions such as eclampsia or rubella)
- Hyperopia of +5.00D or more but less than +7.00D spherical equivalent refractive error in each eye by cycloplegic retinoscopy using cyclopentolate 1%
- Currently under the care of a pediatrician
Who cannot join
- Anisometropia greater than 1.00D (difference in spherical equivalent)
- Strabismus
- Previous history of difficulty with pupillary dilation
- History of cardiac, liver, asthma, or other respiratory disease
- History of ocular disease or active ocular inflammation
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Optometry
Columbus, Ohio, 43210-1240
About this study
To determine if wearing a moderate spectacle under-correction (3.00D) and performing activities designed to stimulate accurate accommodation during a 15-month period will enhance emmetropization in highly hyperopic (between +5.00D and +7.00D) 3-month old infants.
Read the detailed description
The purpose of the project is to determine if emmetropization can be enhanced in very farsighted babies. We will give them glasses with a partial correction, an amount that is less than their full degree of farsightedness but enough to put them in the zone of effective emmetropization. This 'boost' is meant to enable very farsighted babies to use their eyes in a normal way and emmetropize as normal infants. This partial correction would be given at 3 months of age for a period of up to 15 months. A program of visual engagement is also provided in order to encourage the normal development and use of accommodation. As changes in farsightedness occur, the power of the glasses will be reduced at follow up appointments to keep the farsightedness within the zone of effective emmetropization. Once an infant reaches a normal amount of farsightedness, the glasses would be discontinued.
- Conditions
- Hyperopia, Hypermetropia, Farsightedness
- Being tested
- Spectacles
- Keywords
- hyperopia, ocular refraction, infant, vision
- Medical subject headings
- Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpectaclesProcedure or surgery
Also called Under-correction
Infants will receive spectacles with 3.00D of under-correction relative to the spherical equivalent in each eye as measured by the cycloplegic retinoscopy performed at baseline. They will also receive the full amount of measured astigmatism in their glasses. Changes in spectacle lens power will be made as needed at follow-up visits to keep the level of under-correction within 0.50D of the target 3.00D. A program of visual engagement is also provided to encourage the normal development and use of accommodation. Treatment will continue for 15 months (until 18 months of age) or until the infant reaches a spherical equivalent refractive error of +3.00D or less hyperopia.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Infants will receive spectacle under-correction of their hyperopia. Receives: Procedure: Spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be to determine if the criterion level for emmetropization (≤+3.00D by 18 months of age) is met and maintained by at least 70% of treated infants.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Lack of funding support for continued recruitment, enrollment, treatment
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 HyperopiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- The Ohio Lions Eye Research Foundation
- Responsible party
- Principal investigator, Donald Mutti, Ohio State University
- Investigators
- Donald O. Mutti, OD, PhD, Principal investigator, The Ohio State University College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574717
- Sponsor's protocol ID
- 2004H0157
- Status last verified
- Oct 2012
- First submitted
- 11 Dec 2007
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Atkinson J, Anker S, Bobier W, Braddick O, Durden K, Nardini M, Watson P. Normal emmetropization in infants with spectacle correction for hyperopia. Invest Ophthalmol Vis Sci. 2000 Nov;41(12):3726-31.
PubMed 11053269Ingram RM, Gill LE, Lambert TW. Effect of spectacles on changes of spherical hypermetropia in infants who did, and did not, have strabismus. Br J Ophthalmol. 2000 Mar;84(3):324-6. doi: 10.1136/bjo.84.3.324.
PubMed 10684846Mutti DO, Mitchell GL, Jones LA, Friedman NE, Frane SL, Lin WK, Moeschberger ML, Zadnik K. Axial growth and changes in lenticular and corneal power during emmetropization in infants. Invest Ophthalmol Vis Sci. 2005 Sep;46(9):3074-80. doi: 10.1167/iovs.04-1040.
PubMed 16123404Mutti DO, Mitchell GL, Jones LA, Friedman NE, Frane SL, Lin WK, Moeschberger ML, Zadnik K. Refractive astigmatism and the toricity of ocular components in human infants. Optom Vis Sci. 2004 Oct;81(10):753-61. doi: 10.1097/00006324-200410000-00007.
PubMed 15557849Anker S, Atkinson J, Braddick O, Nardini M, Ehrlich D. Non-cycloplegic refractive screening can identify infants whose visual outcome at 4 years is improved by spectacle correction. Strabismus. 2004 Dec;12(4):227-45. doi: 10.1080/09273970490517935.
PubMed 15545141Hung LF, Crawford ML, Smith EL. Spectacle lenses alter eye growth and the refractive status of young monkeys. Nat Med. 1995 Aug;1(8):761-5. doi: 10.1038/nm0895-761.
PubMed 7585177Schaeffel F, Glasser A, Howland HC. Accommodation, refractive error and eye growth in chickens. Vision Res. 1988;28(5):639-57. doi: 10.1016/0042-6989(88)90113-7.
PubMed 3195068Smith EL 3rd, Hung LF. The role of optical defocus in regulating refractive development in infant monkeys. Vision Res. 1999 Apr;39(8):1415-35. doi: 10.1016/s0042-6989(98)00229-6.
PubMed 10343811
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Emmetropization in Hyperopic Infants
- ClinicalTrials.gov ID
- NCT00574717
- Acronym / sponsor ID
- 2004H0157
- Conditions
- Hyperopia, Hypermetropia, Farsightedness
- Keywords
- hyperopia, ocular refraction, infant, vision
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding support for continued recruitment, enrollment, treatment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- The Ohio Lions Eye Research Foundation
- Study start
- Dec 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 Dec 2007 (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 if wearing a moderate spectacle under-correction (3.00D) and performing activities designed to stimulate accurate accommodation during a 15-month period will enhance emmetropization in highly hyperopic (between +5.00D and +7.00D) 3-month old infants.
Detailed description
The purpose of the project is to determine if emmetropization can be enhanced in very farsighted babies. We will give them glasses with a partial correction, an amount that is less than their full degree of farsightedness but enough to put them in the zone of effective emmetropization. This 'boost' is meant to enable very farsighted babies to use their eyes in a normal way and emmetropize as normal infants. This partial correction would be given at 3 months of age for a period of up to 15 months. A program of visual engagement is also provided in order to encourage the normal development and use of accommodation. As changes in farsightedness occur, the power of the glasses will be reduced at follow up appointments to keep the farsightedness within the zone of effective emmetropization. Once an infant reaches a normal amount of farsightedness, the glasses would be discontinued.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: SpectaclesInfants will receive spectacle under-correction of their hyperopia. |
Who may qualify
- Ages
- 8 to 20 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 3 months of age (between 8 weeks and 20 weeks)at the baseline examination
- Either gender, any ethnicity
- Birthweight greater than 2500g
- Normal pregnancy and delivery (including Cesarean section delivery but excluding serious complications or conditions such as eclampsia or rubella)
- Hyperopia of +5.00D or more but less than +7.00D spherical equivalent refractive error in each eye by cycloplegic retinoscopy using cyclopentolate 1%
Key exclusion criteria (5 listed)
- Anisometropia greater than 1.00D (difference in spherical equivalent)
- Strabismus
- Previous history of difficulty with pupillary dilation
- History of cardiac, liver, asthma, or other respiratory disease
- History of ocular disease or active ocular inflammation
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 |
|---|---|---|
| SpectaclesAlso: Under-correctionInfants will receive spectacles with 3.00D of under-correction relative to the spherical equivalent in each eye as measured by the cycloplegic retinoscopy performed at baseline. They will also receive the full amount of measured astigmatism in their glasses. Changes in spectacle lens power will be made as needed at follow-up visits to keep the level of under-correction within 0.50D of the target 3.00D. A program of visual engagement is also provided to encourage the normal development and use of accommodation. Treatment will continue for 15 months (until 18 months of age) or until the infant reaches a spherical equivalent refractive error of +3.00D or less hyperopia. | Procedure or surgery | A |
Primary outcome
The primary outcome will be to determine if the criterion level for emmetropization (≤+3.00D by 18 months of age) is met and maintained by at least 70% of treated infants.
Time frame: 15 months
Results and safety
The study was stopped early (reason given: Lack of funding support for continued recruitment, enrollment, treatment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2012.
- Background: PubMed 11053269Atkinson J, Anker S, Bobier W, Braddick O, Durden K, Nardini M, Watson P. Normal emmetropization in infants with spectacle correction for hyperopia. Invest Ophthalmol Vis Sci. 2000 Nov;41(12):3726-31.
- Background: PubMed 10684846Ingram RM, Gill LE, Lambert TW. Effect of spectacles on changes of spherical hypermetropia in infants who did, and did not, have strabismus. Br J Ophthalmol. 2000 Mar;84(3):324-6. doi: 10.1136/bjo.84.3.324.
- Background: PubMed 16123404Mutti DO, Mitchell GL, Jones LA, Friedman NE, Frane SL, Lin WK, Moeschberger ML, Zadnik K. Axial growth and changes in lenticular and corneal power during emmetropization in infants. Invest Ophthalmol Vis Sci. 2005 Sep;46(9):3074-80. doi: 10.1167/iovs.04-1040.
- Background: PubMed 15557849Mutti DO, Mitchell GL, Jones LA, Friedman NE, Frane SL, Lin WK, Moeschberger ML, Zadnik K. Refractive astigmatism and the toricity of ocular components in human infants. Optom Vis Sci. 2004 Oct;81(10):753-61. doi: 10.1097/00006324-200410000-00007.
- Background: PubMed 15545141Anker S, Atkinson J, Braddick O, Nardini M, Ehrlich D. Non-cycloplegic refractive screening can identify infants whose visual outcome at 4 years is improved by spectacle correction. Strabismus. 2004 Dec;12(4):227-45. doi: 10.1080/09273970490517935.
- Background: PubMed 7585177Hung LF, Crawford ML, Smith EL. Spectacle lenses alter eye growth and the refractive status of young monkeys. Nat Med. 1995 Aug;1(8):761-5. doi: 10.1038/nm0895-761.
- Background: PubMed 3195068Schaeffel F, Glasser A, Howland HC. Accommodation, refractive error and eye growth in chickens. Vision Res. 1988;28(5):639-57. doi: 10.1016/0042-6989(88)90113-7.
- Background: PubMed 10343811Smith EL 3rd, Hung LF. The role of optical defocus in regulating refractive development in infant monkeys. Vision Res. 1999 Apr;39(8):1415-35. doi: 10.1016/s0042-6989(98)00229-6.
- College of Optometry WebsiteLink provided by the sponsor.
- Principal Investigator Web PageLink provided by the sponsor.
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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.
Donald O. Mutti, OD, PhD principal investigator
The Ohio State University College of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Spectacles in people with Hyperopia and Hypermetropia, 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 19 Oct 2012. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of funding support for continued recruitment, enrollment, treatment). Results are not available in the source record.
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?
The primary outcome will be to determine if the criterion level for emmetropization (≤+3.00D by 18 months of age) is met and maintained by at least 70% of treated infants. (time frame: 15 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 NCT00574717, 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 19 Oct 2012.