Enhancement of Emmetropization in Highly Hyperopic Infants

NCT03669146 | Completed Results FDA Device

• 1 other identifier: NEW-33235
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Emmetropization; Refractive Error; Glasses; Accommodation

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Secondary Outcomes (2)

• Peripheral Cycloplegic Refractive Error With SureSight Autorefractor

  18 months

• Accommodative Response With PowerRefractor

  18 months

Study Arms (3)

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.

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.

Device: Glasses

Interventions

Glasses DEVICE

Partial refractive correction in a pair of glasses.

Highly hyperopic subjects corrected; Hyperopic subjects receiving glasses

Eligibility Criteria

• Age: 8 Weeks - 15 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Donald O Mutti, OD, PhD: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

• 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.

  PMID: 40261678 DERIVED

• Morrison 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.

  PMID: 36951871 DERIVED

MeSH Terms

Conditions

Hyperopia; Refractive Errors

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Limitations and Caveats

Small number of participants analyzed.

Results Point of Contact

• Title: Ann Morrison
• Organization: The Ohio State University College of Optometry

morrison.421@osu.edu

614-570-3416

Study Officials

• Donald O Mutti, OD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Ann M Morrison, OD, PhD

  Ohio State University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: A provider other than the investigator(s) will be masked to the primary outcome of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 13, 2018
• Study Start: April 24, 2019
• Primary Completion: January 5, 2023
• Study Completion: January 5, 2023
• Last Updated: July 9, 2024
• Results First Posted: July 9, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)