Myopia Assessment of Two Manufacturing Processes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-02

Study Completion Date

2020-09-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Juvenile Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DOT Spectacle Lenses using Manufacturing Method A

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

Group Type EXPERIMENTAL

SightGlass Vision DOT Spectacle Lenses

Intervention Type DEVICE

Subjects randomized to test vs control, left eyes and right eyes

DOT Spectacle Lenses using Manufacturing Method B

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

Group Type EXPERIMENTAL

SightGlass Vision DOT Spectacle Lenses

Intervention Type DEVICE

Subjects randomized to test vs control, left eyes and right eyes

Interventions

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SightGlass Vision DOT Spectacle Lenses

Subjects randomized to test vs control, left eyes and right eyes

Intervention Type DEVICE

Other Intervention Names

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SightGlass Vision

Eligibility Criteria

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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)

Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes