Myopia Assessment of Two Manufacturing Processes

Completed · Not applicable

Conditions studied: Juvenile Myopia

In brief

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.

Key facts

Study ID

NCT04126057

Run by

SightGlass Vision, Inc.

People needed

50

Starts

2019-12-02

Expected to finish

2020-09-16

Last updated by the study team

2022-01-25

Who can join

Age: 6 and older, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Sabal Eye Care — Longwood, Florida, United States
• Kannarr Eye Care — Pittsburg, Kansas, United States
• Advanced Eyecare PC — Raytown, Missouri, United States
• SUNY School of Optometry — New York, New York, United States
• William J Bogus, OD, FAAO — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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