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OpenTrials
Completed

NCT Number: NCT04126057

Myopia Assessment of Two Manufacturing Processes

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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Key information

Conditions

Juvenile Myopia Eye Diseases Myopia Refractive Errors

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sabal Eye Care, Longwood, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SightGlass Vision DOT Spectacle Lenses

Device

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

Other names: SightGlass Vision

Primary outcomes

  1. Change in Axial Length Progression From Baseline

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

SightGlass Vision, Inc.

Industry

Registry information

Official study title

Myopia Assessment of Two Manufacturing Processes for Myopia Management Lenses (MAPLE)

Acronym: MAPLE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 14, 2019
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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