Myopia Assessment of Two Manufacturing Processes (MAPLE)

SightGlass Vision

Status: Completed

Conditions: Juvenile Myopia

Treatments: Device: SightGlass Vision DOT Spectacle Lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT04126057

CPRO-1908-001

Details and patient eligibility

About

Randomized, controlled, multisite, subject- and observer-masked, contralateral clinical trial of 6-month duration to compare two SightGlass Vision Diffusion Optics Technology (DOT) spectacle lens manufacturing processes in reducing the progression of juvenile myopia.

Enrollment: 50 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children between the ages of 6 and 14 years old (inclusive) with myopia
• Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye
• Difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 0.75 D

Exclusion criteria

• Current use of any myopia control treatment such as atropine, multifocal contact lenses, or orthokeratology (NOTE: Prior bilateral usage acceptable as long as treatment stopped at least 6 months before screening visit. Any subject with a history of unilateral myopia control treatment is excluded.)
• Any ocular or systemic conditions that could influence refractive development or status [e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

DOT Spectacle Lenses using Manufacturing Method A

Experimental group

Description:

Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A

Treatment:

Device: SightGlass Vision DOT Spectacle Lenses

DOT Spectacle Lenses using Manufacturing Method B

Experimental group

Description:

Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B

Treatment:

Device: SightGlass Vision DOT Spectacle Lenses