Investigation of Wearing Compliance of Spectacles for Myopia Control

Completed

• Conditions: Myopia
• Interventions: Device: Myopia control spectacles

• Registration Number: NCT06590441
• Lead Sponsor: CooperVision International Limited (CVIL)

Brief Summary

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

Detailed Description

This unmasked, multi-center, observational study will evaluate the wearing patterns of established (use of ≥3 months) juvenile spectacles wearers. Wearing pattern will be 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 will be used for analysis to minimize 'unusual' wear patterns which may occur early in the study.

Study Timeline

• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-09-04
• Study Start: 2024-09-18
• Study First Posted: 2024-09-19
• Status Verified: 2025-01
• Primary Completion: 2025-01-18
• Study Completion: 2025-01-18
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. They are amblyopic.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Myopia control spectacle wearers	Myopia control spectacles	Established (use of ≥3 months) juvenile myopia control spectacle wearers

Primary Outcome Measures

Name	Time	Method
Wearing pattern of myopia control spectacles	Measured continuously over 1 week of wear	Wearing patterns will be evaluated via the use of temperature sensors fitted to the frame of the spectacles. Temperature readings from the final week of the study will be used to determine when spectacles were worn or removed.

Trial Locations

Locations (4)

Eye2C Ltd; 🇬🇧 Sale, Cheshire, United Kingdom

Susan Hilton Ltd; 🇬🇧 Darwen, England, United Kingdom

Columbo Ltd; 🇬🇧 Oakwood, Leeds, United Kingdom

David Gould Opticians Limited; 🇬🇧 Haslingden, Rossendale, United Kingdom