Myopia Assessment of Two Manufacturing Processes

Juvenile Myopia Clinical Trial

— MAPLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04126057
• Other study ID #: CPRO-1908-001
• Status: Completed
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: September 16, 2020

Study information

• Verified date: December 2021
• Source: SightGlass Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 16, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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)

Related Conditions & MeSH terms

• Juvenile Myopia
• Myopia

Intervention

Device:
• SightGlass Vision DOT Spectacle Lenses
Subjects randomized to test vs control, left eyes and right eyes

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
SightGlass Vision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Axial Length Progression From Baseline	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.	6 months