Myopia
Conditions
Brief summary
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: * do low-dose atropine and soft multifocal contact lenses affect the shape of the peripheral eye? * are changes in peripheral eye shape from these interventions influenced by changes in the focusing system of the eye? Participants will: * have multiple different types of photos taken * have their prescription for glasses/contacts checked * have their eye health checked, including the use of dilating eye drops * be randomly assigned to use eye drops every night or wear special contact lenses daily instead of their typical contacts * will complete five study visits over the course of 12 months 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.
Interventions
0.05% atropine ophthalmic solution
DEVICEMiSight 1-day disposable contact lenses
soft multifocal contact lenses
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* best corrected visual acuity of 20/25 or better in each eye * nearsighted * current contact lens wearer * normal binocular vision (to be determined by an examiner at the first study visit)
Exclusion criteria
* eye diseases (including lazy eye or eye turn) * pregnant, nursing, or planning a pregnancy in the next 12 months * history of refractive surgery (e.g., LASIK) * history of myopia control treatment * sensitivity to anesthetics or preservative in eye drops * difficulty with pupillary dilation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ocular shape | baseline to 12 months | ocular shape, as measured by the ellipsoid fit of the retina acquired by the photos taken with ocular ultrasound (ABSolu, Quantel Medical) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Axial elongation (or regression) | baseline to 12 months | change in axial length of the eye, as measured by Lenstar 900 (Haag-Streit) |
| Change in accommodative response | baseline to 12 months | change in focusing ability of the eye, as measured with near targets and the Grand Seiko WR-5100K |
| Change in refractive error | baseline to 12 months | change in refractive error, as measured with the Grand Seiko WR-5100K |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDonald O Mutti, OD, PhD
Ohio State University
Outcome results
None listed