Investigation of Wearing Compliance of Spectacles for Myopia Control

CooperVision, Inc.

Status

Completed

Conditions

Myopia

Treatments

Device: Myopia control spectacles

Study type

Observational

Funder types

Industry

Identifiers

NCT06590441

EX-MKTG-160

Details and patient eligibility

About

The goal of this observational study was to compare the wearing patterns of spectacles prescribed for myopia control in juvenile wearers.

Full description

This unmasked, multi-center, observational study evaluated the wearing patterns of established (use of ≥3 months) juvenile spectacles wearers. It aimed to compare the wearing patterns of spectacles for myopia control between males and females. Wearing pattern were measured via the use of temperature sensors fitted to the sides of the participant's spectacles. Data from the final week of the 1-month study was used for analysis to minimize 'unusual' wear patterns which may have occurred early in the study.

Enrollment

53 patients

Sex

All

Ages

6 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

They are aged between six and 15 years old.
Their parent or guardian understands the rights of the subject and are willing to sign a statement of informed consent.
They understand the study at a level appropriate for their age and are willing to sign a statement of assent.
They and their parents or guardians are willing and able to follow the protocol.
They currently use spectacle lenses for myopia control and have done so for at least three months.
They agree not to participate in other clinical research for the duration of this study.

Exclusion criteria

They have an unusual ophthalmic history, which in the opinion of the site investigator or Principal Investigator might impact on the successful conduct of the study.
They are amblyopic.