Myopia Control Spectacle Lens Cessation Study (BIRCH)

SightGlass Vision

Status: Active, not recruiting

Conditions: Myopia; Myopia Progression; Juvenile Myopia

Treatments: Device: Spectacle Lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT05893979

CPRO-2303-001

Details and patient eligibility

About

To quantify myopic progression (cycloplegic spherical equivalent refraction - cSER) following the cessation of use of specific spectacle lenses.

To quantify axial length progression following cessation of use of specific spectacle lenses.

Enrollment: 90 estimated patients

Sex: All

Ages: 9 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Previously a successfully completed participant in the CYPRESS Extension study;
• Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
• Willingness to participate in the trial for up to 12 months without contact lens wear;
• The subject's parent(s) or legal guardian(s) must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.

Exclusion criteria

• Known allergy to proparacaine, tetracaine, or tropicamide.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Test Lens Group

Active Comparator group

Treatment:

Device: Spectacle Lenses

Control Lens Group

Active Comparator group

Treatment:

Device: Spectacle Lenses