Control of Myopia Using Novel Spectacle Lens Designs (CYPRESS)

SightGlass Vision

Status: Active, not recruiting

Conditions: Juvenile Myopia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03623074

CPRO-1802-001

Details and patient eligibility

About

Randomized, controlled, multisite, subject-and observer-masked, 3-arm parallel group clinical trial of 36-month duration to evaluate the safety and efficacy of a novel spectacle lens design in reducing the progression of juvenile myopia.

Enrollment: 266 patients

Sex: All

Ages: 6 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children 6-10 years of age (day prior to 10th birthday) at time of informed consent/assent
• SER error between -0.75 and -4.50 D
• SER power between the two eyes must be less than or equal to 1.50 D
• Willingness to participate in the trial for 3 years without content lens wear

Exclusion criteria

• Previous or current use of contact lenses
• Previous or current use of bifocals, progressive addition spectacles lenses
• Previous or current use of myopia control treatment
• Astigmatism worse then -1.25 DC in either eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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266 participants in 3 patient groups

Test Arm 1

Experimental group

Description:

Single vision, impact-resistant spectacle lenses

Treatment:

Device: Novel spectacle lens design

Test Arm 2

Experimental group

Description:

Single vision, impact-resistant spectacle lenses

Treatment:

Device: Novel spectacle lens design

Test Arm 3

Other group

Description:

Single vision, impact-resistant spectacle lenses

Treatment:

Device: Spectacle lenses