Myopia Assessment of Two Manufacturing Processes

Not Applicable

Completed

• Conditions: Juvenile Myopia
• Interventions: Device: SightGlass Vision DOT Spectacle Lenses

• Registration Number: NCT04126057
• Lead Sponsor: SightGlass Vision, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-14
• Study Start: 2019-12-02
• Primary Completion: 2020-09-15
• Study Completion: 2020-09-16
• Results First Submitted: 2021-10-29
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-30
• Last Update Submitted: 2021-12-30
• Results First Posted: 2022-01-25
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DOT Spectacle Lenses using Manufacturing Method A	SightGlass Vision DOT Spectacle Lenses	Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A
DOT Spectacle Lenses using Manufacturing Method B	SightGlass Vision DOT Spectacle Lenses	Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B

Primary Outcome Measures

Name	Time	Method
Change in Axial Length Progression From Baseline	6 months	Change in axial length progression over time between DOT spectacle lenses manufactured by method A versus method B Axial length progression is defined as an axial length elongation that is attributable to myopia.

Trial Locations

Locations (5)

Kannarr Eye Care; 🇺🇸 Pittsburg, Kansas, United States

William J Bogus, OD, FAAO; 🇺🇸 Salt Lake City, Utah, United States

SUNY School of Optometry; 🇺🇸 New York, New York, United States

Advanced Eyecare PC; 🇺🇸 Raytown, Missouri, United States

Sabal Eye Care; 🇺🇸 Longwood, Florida, United States