Choroidal Response to Novel Spectacle Lens to Control Myopia Progression

Not Applicable

Active, not recruiting

• Conditions: Myopia, Progressive
• Interventions: Device: Novel spectacle lens design

• Registration Number: NCT03818880
• Lead Sponsor: SightGlass Vision, Inc.

Brief Summary

Diurnal variations in the thickness of the choroid have been reported in the literature, and, more recently, the role of the choroid has been studied with respect to its role in myopia (near-sightedness) progression.

Detailed Description

Diurnal variations in the thickness of the choroid have been reported in the literature , and, more recently, the role of the choroid has been studied with respect to its role in myopia (near-sightedness) progression. SightGlass Vision, Inc is conducting a multi-site, randomized, controlled, interventional study to confirm the efficacy and safety of spectacle lenses designed to inhibit the progression of myopia by reducing image contrast in peripheral vision. CORE is participating as a clinical site in this three year study which aims to compare changes in ocular length and cycloplegic auto-refraction in children randomised to wear one of either two test or one control spectacle lens designs; the CPRO-1802-001 (Cypress_SG) study. The sponsor is interested in conducting choroidal thickness measurements only at CORE's site by inviting those participants who have already been found eligible for the CPRO-1802-001 study to participate in this parallel study.

Study Timeline

• Study Start: 2018-12-18
• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Primary Completion: 2022-04-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2025-03-25
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Participating in the CPRO-1802-001 (Cypress_SG) study at CORE
• Read and signed an Assent and their parent/guardian has signed an information consent letter

Exclusion Criteria

• Transient health condition which may affect the eye(s) (e.g. a common cold, active allergies, fatigue, etc;)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Novel spectacle lens design	Subjects wearing novel spectacle lenses will be assessed

Primary Outcome Measures

Name	Time	Method
Choroidal thickness	3 years	Measurement of choroidal thickness by Triton optical coherence tomographer (OCT), including post-imaging analysis

Secondary Outcome Measures

Name	Time	Method
Visual field	3 years	Assessment of visual field to determine if changes in peripheral visual function by Humphrey Visual Field Analyzer

Trial Locations

Locations (1)

Centre for Ocular Research and Education; 🇨🇦 Waterloo, Ontario, Canada