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Myopia Assessment of Two Manufacturing Processes (MAPLE)

Primary Purpose

Juvenile Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SightGlass Vision DOT Spectacle Lenses
Sponsored by
SightGlass Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Myopia focused on measuring Myopia

Eligibility Criteria

6 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Sabal Eye Care
  • Kannarr Eye Care
  • Advanced Eyecare PC
  • SUNY School of Optometry
  • William J Bogus, OD, FAAO

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DOT Spectacle Lenses using Manufacturing Method A

DOT Spectacle Lenses using Manufacturing Method B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 10, 2019
Last Updated
December 30, 2021
Sponsor
SightGlass Vision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04126057
Brief Title
Myopia Assessment of Two Manufacturing Processes
Acronym
MAPLE
Official Title
Myopia Assessment of Two Manufacturing Processes for Myopia Management Lenses (MAPLE)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
September 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SightGlass Vision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Myopia
Keywords
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DOT Spectacle Lenses using Manufacturing Method A
Arm Type
Experimental
Arm Description
Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A
Arm Title
DOT Spectacle Lenses using Manufacturing Method B
Arm Type
Experimental
Arm Description
Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B
Intervention Type
Device
Intervention Name(s)
SightGlass Vision DOT Spectacle Lenses
Other Intervention Name(s)
SightGlass Vision
Intervention Description
Subjects randomized to test vs control, left eyes and right eyes
Primary Outcome Measure Information:
Title
Change in Axial Length Progression From Baseline
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Rappon, OD, MS, FAAO
Organizational Affiliation
SightGlass Vision, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Sabal Eye Care
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Kannarr Eye Care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Advanced Eyecare PC
City
Raytown
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
SUNY School of Optometry
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
William J Bogus, OD, FAAO
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Myopia Assessment of Two Manufacturing Processes

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