HyperopiaODSEEHNCT00950924
Optical Defocus to Stimulate Eye Elongation in Hyperopia
A study testing Simultaneous Vision Bifocal Soft Contact Lenses and Single Vision Soft Contact Lenses in people with Hyperopia and Refractive Error, run by Aller, Thomas A., OD at 1 site in United States.
Trial summary
Axial hyperopia results when the length of the eye is too short for the eye to properly focus distance objects on the retina while the focusing system is relaxed. Emmetropization is the process by which the eye actively adjusts various components of the eye to gradually improve the focus of the eye. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperopia, Refractive Error
- What is being tested?
- Simultaneous Vision Bifocal Soft Contact Lenses and Single Vision Soft Contact Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 1 Jan 2022
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 5-12
- Hyperopia > +1.25 each eye (cycloplegic refraction)
- Ability to wear soft contact lenses
Who cannot join
- Amblyopia
- Strabismus
- Astigmatism > 1.00 diopters
- Axial Length > 24.00 mm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Multifocal Contact Lenses to Stimulate Axial Elongation in Axial Hyperopia
Axial hyperopia results when the length of the eye is too short for the eye to properly focus distance objects on the retina while the focusing system is relaxed. Emmetropization is the process by which the eye actively adjusts various components of the eye to gradually improve the focus of the eye. Emmetropization frequently involves either an increase or a decrease in the growth of the eye, particularly during infancy and childhood. Numerous animal studies suggest that if an animal is exposed to retinal images located behind the retina either centrally or peripherally, the eye will grow in the direction of the focused image. If an abnormally short eye has resulted in hyperopia, exposing such an eye to retinal images partially located behind the retina might encourage axial elongation, thus reducing the hyperopia.
Read the detailed description
Hyperopia or farsightedness may cause distance vision and near vision to be blurred. Depending on the severity of the condition and the age of the patient and the status of the binocular vision system, hyperopia can also cause fatigue, asthenopia, headaches, double vision, and amblyopia. Low to moderate amounts of hyperopia rarely cause much difficulty in the young person, but will eventually cause significant near vision problems as the patient ages. Hyperopia can be caused by the eye being too short (axial hyperopia) or by the cornea being too flat or the crystalline lens being to weak (refractive hyperopia). It has been established by the PI that axial growth can be dramatically lessened in children and adolescents with myopia through the use of bifocal contact lenses prescribed in a particular way (The CONTROL Study). Studies by Earl Smith, O.D., Ph.D. have suggested that multi-zonal contact lenses that provide proper axial focus while manipulating peripheral defocus can either discourage or encourage axial growth to treat myopia or hyperopia respectively. In the present study, simultaneous vision bifocal soft contact lenses will be used to encourage axial growth in hyperopic children and adolescents with axial hyperopia in an effort to reduce hyperopia. Subjects will be randomly assigned to wear either bifocal soft contact lenses or single vision soft lenses. The bifocal contact lenses will be prescribed to provide for clear central vision at both distance and near with the near zone of the contact, thus exposing the retina to hyperopic defocus from the distance zone.
- Conditions
- Hyperopia, Refractive Error
- Being tested
- Simultaneous Vision Bifocal Soft Contact Lenses, Single Vision Soft Contact Lenses
- Keywords
- Hyperopia, Refractive Error, Ocular Biometrics, Axial Length, Contact Lenses, Bifocal Contact Lenses
- Medical subject headings
- Hyperopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous Vision Bifocal Soft Contact LensesDevice
Simultaneous Vision Bifocal Soft Contact Lenses will be prescribed such that the distance vision as measured by manifest subjective refraction will be properly corrected by the near vision add power and undercorrected by the distance power.
Single Vision Soft Contact LensesDevice
Single vision soft contact lenses will be prescribed to properly correct the distance vision as measured by manifest subjective refraction.
| Study group | Role | What they receive |
|---|---|---|
| Bifocal Contact Lenses | Experimental | Simultaneous Vision Bifocal Soft Contact Lenses will be prescribed such that the distance vision as measured by manifest subjective refraction will be properly corrected by the near vision add power and undercorrected by the distance power. Receives: Device: Simultaneous Vision Bifocal Soft Contact Lenses |
| Single Vision Soft Contact Lenses | Placebo comparator | Subjects will be fitted with single vision soft contact lenses with goal of corrected emmetropia at a distance of 20 feet. Receives: Device: Single Vision Soft Contact Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
Measured: One year
Secondary outcomes (1)
Refractive Error
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study startJan 2015
- Primary completionOct 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperopiaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aller, Thomas A., OD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas A Aller, O.D., Principal investigator, Unafilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950924
- Sponsor's protocol ID
- NCT00950924
- Acronym
- ODSEEH
- Status last verified
- Jan 2021
- First submitted
- 30 Jul 2009
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Multifocal Contact Lenses to Stimulate Axial Elongation in Axial Hyperopia
- ClinicalTrials.gov ID
- NCT00950924
- Acronym / sponsor ID
- ODSEEH / NCT00950924
- Conditions
- Hyperopia, Refractive Error
- Keywords
- Hyperopia, Refractive Error, Ocular Biometrics, Axial Length, Contact Lenses, Bifocal Contact Lenses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aller, Thomas A., ODUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 3 Aug 2009 (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.
Axial hyperopia results when the length of the eye is too short for the eye to properly focus distance objects on the retina while the focusing system is relaxed. Emmetropization is the process by which the eye actively adjusts various components of the eye to gradually improve the focus of the eye. Emmetropization frequently involves either an increase or a decrease in the growth of the eye, particularly during infancy and childhood. Numerous animal studies suggest that if an animal is exposed to retinal images located behind the retina either centrally or peripherally, the eye will grow in the direction of the focused image. If an abnormally short eye has resulted in hyperopia, exposing such an eye to retinal images partially located behind the retina might encourage axial elongation, thus reducing the hyperopia.
Detailed description
Hyperopia or farsightedness may cause distance vision and near vision to be blurred. Depending on the severity of the condition and the age of the patient and the status of the binocular vision system, hyperopia can also cause fatigue, asthenopia, headaches, double vision, and amblyopia. Low to moderate amounts of hyperopia rarely cause much difficulty in the young person, but will eventually cause significant near vision problems as the patient ages. Hyperopia can be caused by the eye being too short (axial hyperopia) or by the cornea being too flat or the crystalline lens being to weak (refractive hyperopia). It has been established by the PI that axial growth can be dramatically lessened in children and adolescents with myopia through the use of bifocal contact lenses prescribed in a particular way (The CONTROL Study). Studies by Earl Smith, O.D., Ph.D. have suggested that multi-zonal contact lenses that provide proper axial focus while manipulating peripheral defocus can either discourage or encourage axial growth to treat myopia or hyperopia respectively. In the present study, simultaneous vision bifocal soft contact lenses will be used to encourage axial growth in hyperopic children and adolescents with axial hyperopia in an effort to reduce hyperopia. Subjects will be randomly assigned to wear either bifocal soft contact lenses or single vision soft lenses. The bifocal contact lenses will be prescribed to provide for clear central vision at both distance and near with the near zone of the contact, thus exposing the retina to hyperopic defocus from the distance zone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bifocal Contact Lenses | Experimental | Device: Simultaneous Vision Bifocal Soft Contact LensesSimultaneous Vision Bifocal Soft Contact Lenses will be prescribed such that the distance vision as measured by manifest subjective refraction will be properly corrected by the near vision add power and undercorrected by the distance power. |
| Single Vision Soft Contact Lenses | Placebo comparator | Device: Single Vision Soft Contact LensesSubjects will be fitted with single vision soft contact lenses with goal of corrected emmetropia at a distance of 20 feet. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 5-12
- Hyperopia > +1.25 each eye (cycloplegic refraction)
- Ability to wear soft contact lenses
Key exclusion criteria (4 listed)
- Amblyopia
- Strabismus
- Astigmatism > 1.00 diopters
- Axial Length > 24.00 mm
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 |
|---|---|---|
| Simultaneous Vision Bifocal Soft Contact LensesSimultaneous Vision Bifocal Soft Contact Lenses will be prescribed such that the distance vision as measured by manifest subjective refraction will be properly corrected by the near vision add power and undercorrected by the distance power. | Device | Bifocal Contact Lenses |
| Single Vision Soft Contact LensesSingle vision soft contact lenses will be prescribed to properly correct the distance vision as measured by manifest subjective refraction. | Device | Single Vision Soft Contact Lenses |
Primary outcome
Axial length
Time frame: One year
1 secondary outcome
Refractive Error
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
Related trials for Hyperopia
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Clinical Trial With Artiflex Presbyopic (Artiplus)
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The Emmetropization Via Accommodation (EVA) - II Study
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Eye Imaging for the Study of Childhood Myopia
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School-based Myopia Prevention Trial for Children With Insufficient Hyperopic Reserve
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School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve
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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.
Thomas A Aller, O.D. principal investigator
Unafilliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous Vision Bifocal Soft Contact Lenses and Single Vision Soft Contact Lenses in people with Hyperopia and Refractive Error, run by Aller, Thomas A., OD 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 3 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: status not confirmed, as of the sponsor's last update on 12 Jan 2021. 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. Some participants in this study may receive a placebo. 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?
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?
Axial length (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2021.