HyperopiaEVA-IINCT07838597
The Emmetropization Via Accommodation (EVA) - II Study
A study testing Experimental treatment arm in people with Hyperopia and Farsightedness, run by Ohio State University at 1 site in United States.
Trial summary
To determine if wearing a novel treatment during a 15-month period will enhance emmetropization in 4-month-old infants who have demonstrated poor ocular accommodation (eye focusing). Read more about this study
- Who is it for?
- Ages 13 to 19 weeks
- Conditions the study is for
- Hyperopia, Farsightedness, Hypermetropia
- What is being tested?
- Experimental treatment arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2027to 30 Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 19 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed parental permission and HIPAA authorization and willingness to comply with study procedures.
- Infant 13-19 weeks of age at baseline.
- Either sex and any race or ethnicity.
- Good general health based on parent-provided history, normal pregnancy and delivery without serious complications, and birthweight >2500 g.
- Mean MEM accommodative lag >+1.25 D based on three measurements throughout the baseline examination.
- Cycloplegic spherical-equivalent hyperopia ≥+3.50 D in one or both eyes.
Who cannot join
- Astigmatism >2.00 D in either eye.
- Anisometropia >1.50 D spherical equivalent.
- Strabismus.
- Previous difficulty with pupil dilation.
- Cardiac, liver, asthma, or other respiratory disease.
- Ocular disease/abnormality, prior intraocular surgery, retinal detachment, optic nerve hypoplasia, malformation of the eye, cortical visual impairment, or active ocular inflammation.
- Hydrocephalus, Down syndrome, cerebral palsy, severe developmental delay, or seizure disorder.
- A condition preventing spectacle wear for the study duration (e.g., plagiocephaly).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Ohio State University College of Optometry
Columbus, Ohio, 43209
Ann M Morrison, OD, PhD, 614-247-0010, morrison.421@osu.edu
About this study
To determine if wearing a novel treatment during a 15-month period will enhance emmetropization in 4-month-old infants who have demonstrated poor ocular accommodation (eye focusing).
Read the detailed description
Uncorrected hyperopia (farsightedness) in children can lead to significant learning and visual problems, affecting their overall well-being and academic potential. Normally, infants are born with a moderate degree of hyperopia which should decrease as undergo a normal, developmental process called emmetropization, which mostly occurs during the first 18 months of life. Sometimes, this process fails, leaving children with higher-than-normal levels of hyperopia, which significantly increases their risk of developing conditions like strabismus (crossed eyes), amblyopia (lazy eye), and early literacy and scholastic issues. Infants who are at the greatest risk of not undergoing the normal emmetropization process are those with significantly higher levels of hyperopia early in infancy and those with poor ocular accommodation. The emmetropization process is not perfectly understood in human infants but may allow a window of opportunity for early intervention to help reduce the risk of debilitating vision conditions, while the visual system is still plastic. This study seeks to determine if early intervention, specifically partial refractive correction and visual engagement exercises (meant to stimulate ocular accommodation), can help improve the accommodative response and therefore reduce hyperopia in infants at high risk of not undergoing emmetropization. By treating 4-month-old infants with poor accommodation, the study aims to facilitate emmetropization and potentially reduce the risk of long-term visual problems. The study will also explore whether hyperopic defocus or accommodative effort is the primary signal guiding emmetropization, the two major theories of human emmetropization. Positive outcomes from this research could lead to new standards of care for hyperopic infants, potentially preventing a lifetime of vision-related issues and improving early literacy and academic performance.
- Conditions
- Hyperopia, Farsightedness, Hypermetropia
- Being tested
- Experimental treatment arm
- Keywords
- emmetropization
- Medical subject headings
- Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental treatment armCombination product
Infants will receive spectacles that have a prescription relative to the spherical equivalent in each eye as measured by the cycloplegic retinoscopy performed at baseline. Changes in spectacle lens power will be made as needed at follow-up visits to keep the level of under-correction within 0.50D from the study protocol. An experimental non-invasive treatment will be prescribed as well. Treatment will continue until study completion at 18 months of age or until the infant reaches a spherical equivalent refractive error of +2.00D or less hyperopia. Participants will also receive a non-invasive treatment to be used at home.
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | No treatment is administered in this arm. |
| Spectacles and At-Home Therapy | Experimental | Participants will receive experimental treatment. Receives: Combination Product: Experimental treatment arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Accommodation measured with MEM
Change in accommodative lag (in Diopters), measured with Monocular Estimation Method (MEM).
Measured: 14 months
Secondary outcomes (2)
Correlation between refractive error and ocular accommodation measured with MEM
Refractive error will be measured using retinoscopy, in Diopters (D) and ocular accommodation will be measured with MEM retinoscopy, in Diopters (D)
Measured: 14 months
Correlation between refractive error and ocular accommodation measured with PowerRefractor
Refractive error will be measured using retinoscopy, in Diopters (D) and ocular accommodation will be measured with the PlusOptix PowerRefractor, in Diopters (D)
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Apr 2027 (estimated)
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2032 (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.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838597
- Sponsor's protocol ID
- 20261737
- Acronym
- EVA-II
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Emmetropization Via Accommodation (EVA) - II Study
- ClinicalTrials.gov ID
- NCT07838597
- Acronym / sponsor ID
- EVA-II / 20261737
- Conditions
- Hyperopia, Farsightedness, Hypermetropia
- Keywords
- emmetropization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 24 Sep 2026 (actual)
- 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 novel treatment during a 15-month period will enhance emmetropization in 4-month-old infants who have demonstrated poor ocular accommodation (eye focusing).
Detailed description
Uncorrected hyperopia (farsightedness) in children can lead to significant learning and visual problems, affecting their overall well-being and academic potential. Normally, infants are born with a moderate degree of hyperopia which should decrease as undergo a normal, developmental process called emmetropization, which mostly occurs during the first 18 months of life. Sometimes, this process fails, leaving children with higher-than-normal levels of hyperopia, which significantly increases their risk of developing conditions like strabismus (crossed eyes), amblyopia (lazy eye), and early literacy and scholastic issues. Infants who are at the greatest risk of not undergoing the normal emmetropization process are those with significantly higher levels of hyperopia early in infancy and those with poor ocular accommodation. The emmetropization process is not perfectly understood in human infants but may allow a window of opportunity for early intervention to help reduce the risk of debilitating vision conditions, while the visual system is still plastic. This study seeks to determine if early intervention, specifically partial refractive correction and visual engagement exercises (meant to stimulate ocular accommodation), can help improve the accommodative response and therefore reduce hyperopia in infants at high risk of not undergoing emmetropization. By treating 4-month-old infants with poor accommodation, the study aims to facilitate emmetropization and potentially reduce the risk of long-term visual problems. The study will also explore whether hyperopic defocus or accommodative effort is the primary signal guiding emmetropization, the two major theories of human emmetropization. Positive outcomes from this research could lead to new standards of care for hyperopic infants, potentially preventing a lifetime of vision-related issues and improving early literacy and academic performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | –No treatment is administered in this arm. |
| Spectacles and At-Home Therapy | Experimental | Combination Product: Experimental treatment armParticipants will receive experimental treatment. |
Who may qualify
- Ages
- 13 to 19 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Signed parental permission and HIPAA authorization and willingness to comply with study procedures.
- Infant 13-19 weeks of age at baseline.
- Either sex and any race or ethnicity.
- Good general health based on parent-provided history, normal pregnancy and delivery without serious complications, and birthweight >2500 g.
- Mean MEM accommodative lag >+1.25 D based on three measurements throughout the baseline examination.
Key exclusion criteria (8 listed)
- Astigmatism >2.00 D in either eye.
- Anisometropia >1.50 D spherical equivalent.
- Strabismus.
- Previous difficulty with pupil dilation.
- Cardiac, liver, asthma, or other respiratory disease.
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 |
|---|---|---|
| Experimental treatment armInfants will receive spectacles that have a prescription relative to the spherical equivalent in each eye as measured by the cycloplegic retinoscopy performed at baseline. Changes in spectacle lens power will be made as needed at follow-up visits to keep the level of under-correction within 0.50D from the study protocol. An experimental non-invasive treatment will be prescribed as well. Treatment will continue until study completion at 18 months of age or until the infant reaches a spherical equivalent refractive error of +2.00D or less hyperopia. Participants will also receive a non-invasive treatment to be used at home. | Combination product | Spectacles and At-Home Therapy |
Primary outcome
Ocular Accommodation measured with MEM
Time frame: 14 months
Change in accommodative lag (in Diopters), measured with Monocular Estimation Method (MEM).
2 secondary outcomes
Correlation between refractive error and ocular accommodation measured with MEM
Time frame: 14 months
Correlation between refractive error and ocular accommodation measured with PowerRefractor
Time frame: 14 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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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Fresh Corneal Lenticule Implantation in Hyperopic Patients With High Astigmatism
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental treatment arm in people with Hyperopia and Farsightedness, 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 8 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: opening soon, as of the sponsor's last update on 24 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann M Morrison, OD, PhD (614-247-0010, morrison.421@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Accommodation measured with MEM (time frame: 14 months). 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 24 Sep 2026.