Clinical trial

Longitudinal Changes in Eye Shape in Young Adults Treated With Low-Dose Atropine and Soft Multifocal Contact Lenses

Name
2023H0321
Description
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.
Trial arms
Trial start
2024-07-01
Estimated PCD
2025-10-31
Trial end
2025-12-31
Status
Not yet recruiting
Phase
Early phase I
Treatment
Atropine Ophthalmic
0.05% atropine ophthalmic solution
Arms:
Low-dose atropine
MiSight 1-day disposable contact lenses
soft multifocal contact lenses
Arms:
Soft multifocal contact lenses
Size
75
Primary endpoint
Change in ocular shape
baseline to 12 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': '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.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}
Updated at
2024-06-10

1 organization

1 product

1 indication

Product
Atropine
Indication
Myopia