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Myopia Assessment of Two Manufacturing Processes (MAPLE)

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ClinicalTrials.gov Identifier: NCT04126057
Recruitment Status : Not yet recruiting
First Posted : October 14, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
SightGlass Vision, Inc.

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
Juvenile Myopia Device: SightGlass Vision DOT Spectacle Lenses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Myopia Assessment of Two Manufacturing Processes for Myopia Management Lenses (MAPLE)
Estimated Study Start Date : November 24, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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 Name: 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 Name: SightGlass Vision




Primary Outcome Measures :
  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


Secondary Outcome Measures :
  1. Change in spherical equivalent refraction from baseline [ Time Frame: 6 months ]
    Changes in spherical equivalent refraction (SER) as measured by cycloplegic autorefraction over the duration of the study



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126057


Contacts
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Contact: Joseph Rappon, OD, MS, FAAO 678-643-9117 joe@sightglassvision.com
Contact: Vanessa Tasso, MA, MBA 949-751-7039 vanessa@sightglassvision.com

Locations
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United States, Florida
Sabal Eye Care Not yet recruiting
Longwood, Florida, United States, 32779
Contact: Renee Warren    407-869-4733    sabaleyecare@gmail.com   
Principal Investigator: Christopher Pearson, OD         
United States, Kansas
Kannarr Eye Care Not yet recruiting
Pittsburg, Kansas, United States, 66762
Contact: Jamie Torrance    620-235-1737    jtorrance@kannarreyecare.com   
Principal Investigator: Shane Kannarr, OD         
United States, Missouri
Advanced Eyecare PC Not yet recruiting
Raytown, Missouri, United States, 64133
Contact: Tamara Urias    816-353-1872    tammy@bso-ae.com   
Principal Investigator: Richard Wilson, OD         
United States, New York
SUNY School of Optometry Not yet recruiting
New York, New York, United States, 10036
Contact: Monica Joao    212-938-4052    mjoao@sunyopt.edu   
Principal Investigator: Franklin Bui, OD         
United States, Utah
William J Bogus, OD, FAAO Not yet recruiting
Salt Lake City, Utah, United States, 84106
Contact: Cris Bogus       crisbogus@msn.com   
Principal Investigator: William Bogus, OD, FAAO         
Sponsors and Collaborators
SightGlass Vision, Inc.
Investigators
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Study Chair: Joseph Rappon, OD, MS, FAAO SightGlass Vision, Inc.

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Responsible Party: SightGlass Vision, Inc.
ClinicalTrials.gov Identifier: NCT04126057     History of Changes
Other Study ID Numbers: CPRO-1908-001
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by SightGlass Vision, Inc.:
Myopia
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases