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The goal of this clinical trial is to study changes in eye shape of nearsighted young adults using low-dose atropine eye drops or soft multifocal contact lenses. The main questions it aims to answer are:
Participants will:
Researchers will compare young adults using low-dose atropine to those wearing soft multifocal contact lenses and to those using no intervention to see if using these interventions affects retinal shape.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation | No Intervention | Participants randomized to the observation arm will receive no intervention. | |
| Low-dose atropine | Experimental | Participants randomized to low-dose atropine will instill one drop of 0.05% atropine in each eye at bedtime for 12 months. |
|
| Soft multifocal contact lenses | Experimental | Participants randomized to soft multifocal contact lenses will wear MiSight 1-day disposable contact lenses for 5-7 days per week for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine Ophthalmic | Drug | 0.05% atropine ophthalmic solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ocular shape | ocular shape, as measured by the ellipsoid fit of the retina acquired by the photos taken with ocular ultrasound (ABSolu, Quantel Medical) | baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Axial elongation (or regression) | change in axial length of the eye, as measured by Lenstar 900 (Haag-Streit) | baseline to 12 months |
| Change in accommodative response | change in focusing ability of the eye, as measured with near targets and the Grand Seiko WR-5100K |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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The participants and the examining investigator will not be masked to intervention. All measurements are objective in nature and not subject to examiner bias. All data images acquired will be coded to obscure participant ID by a study team member masked to intervention. This coding will allow for the examining investigator to complete image processing while masked to randomization assignment, thereby minimizing the chance of bias.
| MiSight 1-day disposable contact lenses |
| Device |
soft multifocal contact lenses |
|
| baseline to 12 months |
| Change in refractive error | change in refractive error, as measured with the Grand Seiko WR-5100K | baseline to 12 months |