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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glasses | Device | Partial refractive correction in a pair of glasses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald O Mutti, OD, PhD | Ohio State University | Principal Investigator |
| Ann M Morrison, OD, PhD | Ohio State University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40261678 | Derived | 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. | |
| 36951871 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hyperopic Subjects Receiving 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. Glasses: Partial refractive correction in a pair of glasses. |
| FG001 | Hyperopic Subjects Uncorrected | 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. |
| FG002 | Highly Hyperopic Subjects Corrected | 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. Glasses: Partial refractive correction in a pair of glasses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hyperopic Subjects Receiving 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. Glasses: Partial refractive correction in a pair of glasses. |
| BG001 | Hyperopic Subjects Uncorrected |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subject numbers here do not match initial projected subject numbers due to participant drop outs (2 in hyperopic subjects receiving glasses; 1 in hyperopic subjects uncorrected) | Posted | Mean | Standard Deviation | Diopters | 18 months | Pairs of eyes | Pairs of eyes |
|
15 months
All-Cause Mortality: No participants in the study died Serious Adverse Events: No participants developed any serious adverse events Other (Not Including Serious) Adverse Events: No adverse events reported from participants
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hyperopic Subjects Receiving 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. Glasses: Partial refractive correction in a pair of glasses. |
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Small number of participants analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann Morrison | The Ohio State University College of Optometry | 614-570-3416 | morrison.421@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2024 | Apr 18, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 6, 2024 | Apr 18, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006956 | Hyperopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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A provider other than the investigator(s) will be masked to the primary outcome of the study.
| 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. | 18 months |
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. |
| BG002 | Highly Hyperopic Subjects Corrected | 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. Glasses: Partial refractive correction in a pair of glasses. |
| BG003 | Total | Total of all reporting groups |
| Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Hyperopic Subjects Uncorrected | 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. |
| OG002 | Highly Hyperopic Subjects Corrected | 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. Glasses: Partial refractive correction in a pair of glasses. |
|
|
| Secondary | 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. | Number analyzed is slightly less due to drop outs of participants (2 in treatment/hyperopic subjects with glasses; 1 observation/uncorrected no glasses) | Posted | Mean | Standard Deviation | Diopters | 18 months | Pairs of eyes | Pairs of eyes |
|
|
|
| Secondary | 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. | Final number analyzed slightly less due to participant drop out (2 in treatment/hyperopic subjects receiving glasses and 1 observation/hyperopic subjects uncorrected) | Posted | Mean | Standard Deviation | Diopters | 18 months | Pairs of eyes | Pairs of eyes |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Hyperopic Subjects Uncorrected | 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. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Highly Hyperopic Subjects Corrected | 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. Glasses: Partial refractive correction in a pair of glasses. | 0 | 5 | 0 | 5 | 0 | 5 |
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| Relative Temporal Spherical Equivalent Refractive Error |
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