Atropine + Contact Lenses for Near-sightedness
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, you will be randomly assigned to use either eye drops or special contact lenses instead of your typical contacts.
What data supports the effectiveness of the treatment Atropine + Contact Lenses for Near-sightedness?
Is the combination of atropine eye drops and MiSight contact lenses safe for humans?
How does the Atropine + MiSight contact lenses treatment for near-sightedness differ from other treatments?
This treatment combines low-dose atropine eye drops with MiSight contact lenses, which are designed to create a specific focus pattern on the eye to slow myopia progression. This combination has shown effectiveness in reducing the rate of myopia progression more than using either component alone, making it a novel approach compared to traditional single-method treatments like glasses or atropine alone.14589
Research Team
Donald O Mutti, OD, PhD
Principal Investigator
Ohio State University
Eligibility Criteria
This trial is for nearsighted young adults who currently wear contact lenses, have normal binocular vision, and a visual acuity of 20/25 or better. They will be assessed at the first visit to confirm eligibility.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomly assigned to use low-dose atropine eye drops every night or wear soft multifocal contact lenses daily for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Atropine Ophthalmic
- MiSight 1-day disposable contact lenses
Atropine Ophthalmic is already approved in United States, European Union, Canada for the following indications:
- Myopia control in children
- Pupil dilation for diagnostic purposes
- Myopia control in children
- Pupil dilation for diagnostic purposes
- Myopia control in children
- Pupil dilation for diagnostic purposes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University
Lead Sponsor