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MAPLE: Myopia Assessment of Two Manufacturing Processes

Sponsor
SightGlass Vision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04126057
Collaborator
(none)
50
Enrollment
5
Locations
2
Arms
9.5
Actual Duration (Months)
10
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SightGlass Vision DOT Spectacle Lenses
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Myopia Assessment of Two Manufacturing Processes for Myopia Management Lenses (MAPLE)
Actual Study Start Date :
Dec 2, 2019
Actual Primary Completion Date :
Sep 15, 2020
Actual Study Completion Date :
Sep 16, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: DOT Spectacle Lenses using Manufacturing Method A

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

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

    		•
    Experimental: DOT Spectacle Lenses using Manufacturing Method B

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 14 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sabal Eye Care Longwood Florida United States 32779
    2 Kannarr Eye Care Pittsburg Kansas United States 66762
    3 Advanced Eyecare PC Raytown Missouri United States 64133
    4 SUNY School of Optometry New York New York United States 10036
    5 William J Bogus, OD, FAAO Salt Lake City Utah United States 84106

    Sponsors and Collaborators

    • SightGlass Vision, Inc.

    Investigators

    • Study Chair: Joseph Rappon, OD, MS, FAAO, SightGlass Vision, Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    SightGlass Vision, Inc.
    ClinicalTrials.gov Identifier:
    NCT04126057
    Other Study ID Numbers:
    • CPRO-1908-001
    First Posted:
    Oct 14, 2019
    Last Update Posted:
    Jan 25, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by SightGlass Vision, Inc.
    Myopia
    Additional relevant MeSH terms:
    Myopia

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title DOT Spectacle Lenses Test DOT Spectacle Lenses Control
    Arm/Group Description Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes
    Period Title: Overall Study
    STARTED 50 50
    COMPLETED 47 46
    NOT COMPLETED 3 4

    Baseline Characteristics

    Arm/Group Title DOT Spectacle Lenses Test DOT Spectacle Lenses Control Total
    Arm/Group Description Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes Total of all reporting groups
    Overall Participants 43 43 43
    Overall Eyes 43 43 86
    Age (Eyes) [Count of Units]
    <=18 years
    43
    43
    86
    Between 18 and 65 years
    0
    0
    0
    >=65 years
    0
    0
    0
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    11.67
    (2.073)
    11.67
    (2.073)
    11.67
    (2.073)
    Sex: Female, Male (Eyes) [Count of Units]
    Female
    21
    21
    42
    Male
    22
    22
    44
    Ethnicity (NIH/OMB) (Eyes) [Count of Units]
    Hispanic or Latino
    6
    6
    12
    Not Hispanic or Latino
    37
    37
    74
    Unknown or Not Reported
    0
    0
    0
    Race (NIH/OMB) (Eyes) [Count of Units]
    American Indian or Alaska Native
    5
    5
    10
    Asian
    2
    2
    4
    Native Hawaiian or Other Pacific Islander
    0
    0
    0
    Black or African American
    9
    9
    18
    White
    27
    27
    54
    More than one race
    0
    0
    0
    Unknown or Not Reported
    0
    0
    0
    Region of Enrollment (Eyes) [Number]
    United States
    43
    43
    86

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title DOT Spectacle Lenses Using Test DOT Spectacle Lenses Using Control
    Arm/Group Description Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes
    Measure Participants 43 43
    Measure Eyes 43 43
    Mean (Standard Deviation) [mm]
    0.046
    (0.139)
    0.047
    (0.128)

    Adverse Events

    Time Frame 6 months
    Adverse Event Reporting Description
    Arm/Group Title DOT Spectacle Lenses Using Test DOT Spectacle Lenses Using Control
    Arm/Group Description Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes
    All Cause Mortality
    DOT Spectacle Lenses Using Test DOT Spectacle Lenses Using Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/43 (0%) 0/43 (0%)
    Serious Adverse Events
    DOT Spectacle Lenses Using Test DOT Spectacle Lenses Using Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/43 (0%) 0/43 (0%)
    Other (Not Including Serious) Adverse Events
    DOT Spectacle Lenses Using Test DOT Spectacle Lenses Using Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/43 (0%) 0/43 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Results Point of Contact

    Name/Title Joe Rappon, OD, MS, FAAC
    Organization SightGlass Vision, Inc.
    Phone 678-642-9117
    Email joe@sightglassvision.com
    Responsible Party:
    SightGlass Vision, Inc.
    ClinicalTrials.gov Identifier:
    NCT04126057
    Other Study ID Numbers:
    • CPRO-1908-001
    First Posted:
    Oct 14, 2019
    Last Update Posted:
    Jan 25, 2022
    Last Verified:
    Dec 1, 2021