NCT03669146

Enhancement of Emmetropization in Highly Hyperopic Infants

The Enhancement Via Accommodation (EVA) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Donald O Mutti, OD, PhD · Academic / Other
• Sex: All
• Age: 8 Weeks – 15 Weeks
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Glasses	Partial refractive correction in a pair of glasses.

Timeline

• Start date: 2019-04-24
• Primary completion: 2023-01-05
• Completion: 2023-01-05
• First posted: 2018-09-13
• Last updated: 2024-07-09
• Results posted: 2024-07-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study