An interventional study of Glasses in Hyperopia, sponsored by Donald O Mutti, OD, PhD. Completed at 1 site in United States. Open to participants aged 8 Weeks to 15 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by Donald O Mutti, OD, PhD · Not applicable, Interventional, and Treatment
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.
156 studies on the registry are indexed under Hyperopia; 20 are open to participants now.
This study's enrollment of 35 is below the median of 60 across 125 interventional studies indexed under Hyperopia.
Browse Hyperopia studies →This is the only study on the registry with Donald O Mutti, OD, PhD as lead sponsor.
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Exclusion Criteria:
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
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.
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
Partial refractive correction in a pair of glasses.
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.
Time frame: 18 months
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.
Time frame: 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.
Time frame: 18 months
| Milestone | Hyperopic Subjects Receiving Glasses | Hyperopic Subjects Uncorrected | Highly Hyperopic Subjects Corrected |
|---|---|---|---|
| Started | 15 | 15 | 5 |
| Completed | 13 | 14 | 5 |
| Not completed | 2 | 1 | 0 |
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.
| Diopters | Hyperopic Subjects Receiving Glasses | Hyperopic Subjects Uncorrected | Highly Hyperopic Subjects Corrected |
|---|---|---|---|
| Central Cycloplegic Refractive Error With Retinoscopy | 1.6 ± 0.6 | 1.2 ± 0.7 | 2.8 ± 1.2 |
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.
| Diopters | Hyperopic Subjects Receiving Glasses | Hyperopic Subjects Uncorrected | Highly Hyperopic Subjects Corrected |
|---|---|---|---|
| Central Spherical Equivalent Refractive Error | 2.15 ± 0.61 | 1.99 ± 1.18 | 4.11 ± 1.11 |
| Relative Nasal Spherical Equivalent Refractive Error | -0.28 ± 0.89 | -0.19 ± 0.6 | -0.52 ± 0.25 |
| Relative Temporal Spherical Equivalent Refractive Error | -1.25 ± 1.17 | -0.81 ± 0.77 | -2.21 ± 0.61 |
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.
| Diopters | Hyperopic Subjects Receiving Glasses | Hyperopic Subjects Uncorrected | Highly Hyperopic Subjects Corrected |
|---|---|---|---|
| Accommodative Response With PowerRefractor | 2.21 ± 0.00 | 2.09 ± 0.22 | 1.97 ± 0.23 |
Collected over 15 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hyperopic Subjects Receiving Glasses | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Hyperopic Subjects Uncorrected | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Highly Hyperopic Subjects Corrected | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(Days) | Hyperopic Subjects Receiving Glasses | Hyperopic Subjects Uncorrected | Highly Hyperopic Subjects Corrected | Total |
|---|---|---|---|---|
| Mean | 81.9 ± 10.2 | 79.0 ± 9.0 | 78.6 ± 8.7 | 80.2 ± 9.3 |
| Sex: Female, Male(Participants) | Hyperopic Subjects Receiving Glasses | Hyperopic Subjects Uncorrected | Highly Hyperopic Subjects Corrected | Total |
|---|---|---|---|---|
| Female | 9 | 7 | 4 | 20 |
| Male | 6 | 8 | 1 | 15 |
| Ethnicity (NIH/OMB)(Participants) | Hyperopic Subjects Receiving Glasses | Hyperopic Subjects Uncorrected | Highly Hyperopic Subjects Corrected | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 15 | 15 | 5 | 35 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Hyperopic Subjects Receiving Glasses | Hyperopic Subjects Uncorrected | Highly Hyperopic Subjects Corrected | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 1 | 1 |
| White | 14 | 15 | 4 | 33 |
| More than one race | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Hyperopic Subjects Receiving Glasses | Hyperopic Subjects Uncorrected | Highly Hyperopic Subjects Corrected | Total |
|---|---|---|---|---|
| United States | 15 | 15 | 5 | 35 |
PDFs hosted by the registry, ClinicalTrials.gov.
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