Enhancement of Emmetropization in Highly Hyperopic Infants

Not Applicable

Completed

Conditions: Hyperopia

Interventions: Device: Glasses

Registration Number: NCT03669146

Lead Sponsor: Donald O Mutti, OD, PhD

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperopic subjects receiving glasses	Glasses	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.
Highly hyperopic subjects corrected	Glasses	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.

Primary Outcome Measures

Name	Time	Method
Central Cycloplegic Refractive Error With Retinoscopy	18 months	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.

Secondary Outcome Measures

Name	Time	Method
Peripheral Cycloplegic Refractive Error With SureSight Autorefractor	18 months	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.
Accommodative Response With PowerRefractor	18 months	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.