HyperopiaNCT03669146
Enhancement of Emmetropization in Highly Hyperopic Infants
A study testing Glasses in people with Hyperopia, run by Donald O Mutti, OD, PhD at 1 site in United States.
Trial summary
Infants do not usually wear glasses because they usually do not need them to see clearly. Most infants are born with a moderate amount of farsightedness. Most infants then undergo a natural process called 'emmetropization' that reduces the amount of farsightedness. Read more about this study
- Who is it for?
- Ages 8 to 15 weeksHealthy volunteers can take part
- Conditions the study is for
- Hyperopia
- What is being tested?
- Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2019to 5 Jan 2023
- Phase
- Interventional
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 15 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: between 8 and 15 weeks at 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 greater than or equal to +5.00 Diopters (D) in the spherical component of refractive error in one or both eyes measured with cycloplegic retinoscopy using 1% cyclopentolate
- Infants with a refractive error of greater than or equal to +5.00D but less than or equal to +7.00D in the spherical component of refractive error will be randomized to treatment (partial correction with accommodative training) or observation only.
- Infants with greater than +7.00D in the spherical component of refractive error will receive treatment
Who cannot join
- Astigmatism greater than 2.00D in either eye
- Anisometropia greater than 1.50D (spherical equivalent)
- History of strabismus surgery
- History of difficulty with pupillary dilation
- History of cardiac, liver, asthma, or other respiratory disease
- History of ocular disease, retinal detachment, severe macular dragging, intraocular surgery, optic nerve hypoplasia, malformations of the eye, cortical visual impairment or active inflammation
- History of hydrocephalus, Down syndrome, cerebral palsy, developmental delay, seizure disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Enhancement Via Accommodation (EVA) Study
Infants do not usually wear glasses because they usually do not need them to see clearly. Most infants are born with a moderate amount of farsightedness. Most infants then undergo a natural process called 'emmetropization' that reduces the amount of farsightedness. However, up to 10% of infants don't emmetropize and end up with very farsighted prescriptions. Farsighted infants must use extra focusing effort to see clearly, which may make their eyes cross and perhaps cause a "lazy eye". If infants avoid this effort and their vision stays blurred into childhood, they may develop two lazy eyes. Farsightedness in school-aged children makes reading and learning more difficult. New studies in animals and in humans show that infant eyes will emmetropize best if they have just a normal, moderate amount of farsightedness. The infant eye must be in this normal target zone in order to emmetropize. If a baby were given glasses with the full prescription to correct all of his farsightedness, the eyes would also be out of the target zone and would not receive any signal to grow. The best strategy might be to give a partial spectacle correction for the farsightedness, just enough to put them in the zone that is most effective for emmetropization.
The purpose of this project is to determine if emmetropization can be enhanced in very farsighted babies. We will give them glasses with a partial correction and accommodative (eye focusing) training. The partial correction is an amount that is less than their full degree of farsightedness but enough to put them in the zone of effective emmetropization. As changes in farsightedness occur, the power of the glasses will be reduced to keep the farsightedness within the target zone. If an infant reaches a normal amount of farsightedness, the glasses will be discontinued. The comparison group will be farsighted babies who receive the current standard of care, namely no correction. The main outcome of the study will be whether there is a significant difference in the decrease of farsightedness between the two groups when the infants are 18 months of age.
If emmetropization can be enhanced in very farsighted babies, the risk of developing crossed or lazy eye will be reduced. The lifelong need for spectacles, contact lenses, or refractive surgery for high amounts of farsightedness would also be reduced. Positive results might also make infant eye examinations more common and place a new therapeutic option in clinicians' hands.
- Conditions
- Hyperopia
- Being tested
- Glasses
- Keywords
- Emmetropization, Refractive Error, Glasses, Accommodation
- 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.
GlassesDevice
Partial refractive correction in a pair of glasses.
| Study group | Role | What they receive |
|---|---|---|
| Hyperopic subjects receiving glasses | Experimental | Randomized +5.00 to +7.00 diopter hyperopic subjects that will receive partial refractive correction and will be instructed to do accommodation exercises on a daily basis. Receives: Device: Glasses |
| Hyperopic subjects uncorrected | No intervention | Randomized +5.00 to +7.00 diopter hyperopic subjects that will serve as the control to the experimental arm who will receive no correction but be observed for the duration of the study. |
| Highly hyperopic subjects corrected | Active comparator | If a subject is found to be greater than +7.00 diopters hyperopic during the screening phase of the study, they will receive glasses correction and be followed during the study period. Receives: Device: Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Cycloplegic Refractive Error With Retinoscopy
The subject's central refractive error will be measured (in Diopters) with cycloplegic retinoscopy to determine if partial refractive correction and accommodative training can enhance emmetropization in highly hyperopic infants. Successful enhancement is defined as being an average of 1.75 Diopters less hyperopic than control subjects at 18 months.
Measured: 18 months
Secondary outcomes (2)
Peripheral Cycloplegic Refractive Error With SureSight Autorefractor
The subject's central and peripheral refractive error will be measured (in Diopters) with the SureSight autorefractor to determine if partial refractive correction and accommodative training can enhance emmetropization through modulation of ocular shape in highly hyperopic infants.
Measured: 18 months
Accommodative Response With PowerRefractor
The subject's accommodative ability will be measured objectively with a PowerRefractor autorefractor to determine determine if partial refractive correction and accommodative training can enhance emmetropization through modulation of accommodation in highly hyperopic infants.
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 posted13 Sep 2018
- Study start24 Apr 2019
- Primary completion5 Jan 2023
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Donald O Mutti, OD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Donald O Mutti, OD, PhD, Ohio State University
- Investigators
- Donald O Mutti, OD, PhD, Principal investigator, Ohio State UniversityAnn M Morrison, OD, PhD, Study chair, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669146
- Sponsor's protocol ID
- NEW-33235
- Status last verified
- Jun 2024
- First submitted
- 11 Sep 2018
- Last updated
- 9 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Morrison AM, Robich ML, Jordan LA, Sinnott LT, Mutti DO. Emmetropization in highly hyperopic infants: A randomized clinical trial of partial refractive correction. Optom Vis Sci. 2025 May 1;102(5):310-319. doi: 10.1097/OPX.0000000000002254. Epub 2025 Apr 10.
PubMed 40261678Morrison AM, Mutti DO. Evaluation of a Pilot Protocol for Detecting Infant Hyperopia. Optom Vis Sci. 2023 May 1;100(5):304-311. doi: 10.1097/OPX.0000000000002011. Epub 2023 Mar 23.
PubMed 36951871