Spectacle Lens Visual Acuity Assessments Study (CEDAR)

SightGlass Vision

Status: Active, not recruiting

Conditions: Myopia; Myopia Progression; Juvenile Myopia

Treatments: Device: Spectacle lenses; Device: Novel spectacle lens design

Study type: Interventional

Funder types: Industry

Identifiers

NCT05650190

CPRO-2209-001

Details and patient eligibility

About

This is a two-arm parallel group, non-dispensing study. Participants will be existing active CYPRESS Extension (CPRO-1802-002) subjects. Subjects will undergo additional visual performance assessments.

Enrollment: 51 patients

Sex: All

Ages: 9 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Existing subject from the CYPRESS Extension study (CPRO-1802-002)
• Ability to comply with study assessments
• The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed coy of the form

Exclusion criteria

• Any current ocular infection, inflammation or irritation likely to affect vision

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups, including a placebo group

Test Arm

Experimental group

Description:

Single vision, impact resistant spectacle lenses; Test Arm

Treatment:

Device: Novel spectacle lens design

Control Arm

Placebo Comparator group

Description:

Single vision, impact resistant spectacle lenses; Control Arm

Treatment:

Device: Spectacle lenses