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Spectacle Lens Visual Acuity Assessments Study (CEDAR)

Primary Purpose

Myopia, Myopia Progression, Juvenile Myopia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Novel spectacle lens design
Spectacle lenses
Sponsored by
SightGlass Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

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

Inclusion Criteria: Existing subject from the CYPRESS Extension study (CPRO-1802-002) Ability to comply with study assessments The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed coy of the form Exclusion Criteria: Any current ocular infection, inflammation or irritation likely to affect vision

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test Arm

Control Arm

Arm Description

Single vision, impact resistant spectacle lenses; Test Arm

Single vision, impact resistant spectacle lenses; Control Arm

Outcomes

Primary Outcome Measures

Visual Acuity
Reading Speed (maximum words per minute)

Secondary Outcome Measures

Near Visual Acuity with Glare
Mean and Standard Deviation at 15 minutes (short duration test)

Full Information

First Posted
November 28, 2022
Last Updated
April 10, 2023
Sponsor
SightGlass Vision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05650190
Brief Title
Spectacle Lens Visual Acuity Assessments Study
Acronym
CEDAR
Official Title
Spectacle Lenses Visual Acuity Assessments Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
February 10, 2023 (Actual)
Study Completion Date
April 30, 2023 (Anticipated)

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
No

5. Study Description

Brief Summary
This is a two-arm parallel group, non-dispensing study. Participants will be existing active CYPRESS Extension (CPRO-1802-002) subjects. Subjects will undergo additional visual performance assessments.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Test Arm
Arm Type
Experimental
Arm Description
Single vision, impact resistant spectacle lenses; Test Arm
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
Single vision, impact resistant spectacle lenses; Control Arm
Intervention Type
Device
Intervention Name(s)
Novel spectacle lens design
Intervention Description
Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia
Intervention Type
Device
Intervention Name(s)
Spectacle lenses
Intervention Description
Single vision, impact resistant spectacle lenses
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Reading Speed (maximum words per minute)
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Near Visual Acuity with Glare
Description
Mean and Standard Deviation at 15 minutes (short duration test)
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Existing subject from the CYPRESS Extension study (CPRO-1802-002) Ability to comply with study assessments The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed coy of the form Exclusion Criteria: Any current ocular infection, inflammation or irritation likely to affect vision
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
Vision Optique
City
Houston
State/Province
Texas
ZIP/Postal Code
77205
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

Spectacle Lens Visual Acuity Assessments Study

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