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Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast (WALNUT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03761758
Recruitment Status : Completed
First Posted : December 3, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
SightGlass Vision, Inc.

Study Description
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Brief Summary:
Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric acceptability across three iterations of a novel spectacle lens design.

Condition or disease Intervention/treatment Phase
Myopia Device: Spectacle lenses Not Applicable

Detailed Description:
This feasibility study was conducted to assess the performance of three experimental spectacle lens designs (spectacle lenses) in children between 6 and 9 years of age with myopia.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Device Feasibility
Official Title: Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : July 19, 2018
Actual Study Completion Date : July 19, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Lens Design 1
Spectacle lenses design 1, fitted into spectacle frames
 Device: Spectacle lenses
Spectacle lenses with clear central apertures
Experimental: Lens Design 2
Spectacle lenses design 2, fitted into spectacle frames
 Device: Spectacle lenses
Spectacle lenses with clear central apertures
Experimental: Lens Design 3
Spectacle lenses design 3, fitted into spectacle frames
 Device: Spectacle lenses
Spectacle lenses with clear central apertures


Outcome Measures
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Primary Outcome Measures :
  1. Distance Visual Acuity [ Time Frame: 2 weeks ]
    Measurement of best corrected distance visual acuity

  2. Contrast Sensitivity [ Time Frame: 2 weeks ]
    Measurement of contrast sensitivity

  3. Subjective Responses [ Time Frame: 2 weeks ]
    Assessment of subject responses related to wear time of spectacles


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages between 6 and 12 years
  • Myopia between -1.00 and -4.00 D

Exclusion Criteria:

  • Participating in any clinical or other research study
  • Contact lens wearer
Contacts and Locations
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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): NCT03761758


Locations
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Canada, Ontario
Centre for Ocular Research & Education
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
SightGlass Vision, Inc.
Investigators
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Study Director: Joe Rappon, OD, MS SightGlass Vision
More Information
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Responsible Party: SightGlass Vision, Inc.
ClinicalTrials.gov Identifier: NCT03761758    
Other Study ID Numbers: P/639/18/SG
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases