Control of Myopia Using Novel Spectacle Lens Designs

NCT ID: NCT03623074

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-16

Study Completion Date

2026-03-31

Brief Summary

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Randomized, controlled, multisite, subject-and observer-masked, 3-arm parallel group clinical trial of 36-month duration to evaluate the safety and efficacy of a novel spectacle lens design in reducing the progression of juvenile myopia.

Detailed Description

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Conditions

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Juvenile Myopia

Keywords

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants and parents of participants will be masked. Investigational site staff tasked with measuring key primary variables (i.e., axial length and SER) will be masked.

Study Groups

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Test Arm 1

Single vision, impact-resistant spectacle lenses

Group Type EXPERIMENTAL

Novel spectacle lens design

Intervention Type DEVICE

Use of lenses may reduce the rate of progression of juvenile myopia

Test Arm 2

Single vision, impact-resistant spectacle lenses

Group Type EXPERIMENTAL

Novel spectacle lens design

Intervention Type DEVICE

Use of lenses may reduce the rate of progression of juvenile myopia

Test Arm 3

Single vision, impact-resistant spectacle lenses

Group Type OTHER

Spectacle lenses

Intervention Type DEVICE

Use of lenses may reduce the rate of progression of juvenile myopia

Interventions

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Novel spectacle lens design

Use of lenses may reduce the rate of progression of juvenile myopia

Intervention Type DEVICE

Spectacle lenses

Use of lenses may reduce the rate of progression of juvenile myopia

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Children 6-10 years of age (day prior to 10th birthday) at time of informed consent/assent
* SER error between -0.75 and -4.50 D
* SER power between the two eyes must be less than or equal to 1.50 D
* Willingness to participate in the trial for 3 years without content lens wear

Exclusion Criteria

* Previous or current use of contact lenses
* Previous or current use of bifocals, progressive addition spectacles lenses
* Previous or current use of myopia control treatment
* Astigmatism worse then -1.25 DC in either eye
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SightGlass Vision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph Rappon, OD, MS, FAAO

Role: STUDY_CHAIR

SightGlass Vision, Inc.

Locations

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Golden Optometric Group

Whittier, California, United States

Site Status

Sabal Eye Care

Longwood, Florida, United States

Site Status

Visual Performance Center

Pensacola, Florida, United States

Site Status

Kannarr Eye Care

Pittsburg, Kansas, United States

Site Status

Eye Associates of Northeast Louisiana (DBA Haik Humble Eye Center) Research Dept

West Monroe, Louisiana, United States

Site Status

Advanced Eyecare, PC

Raytown, Missouri, United States

Site Status

SUNY School of Optometry

New York, New York, United States

Site Status

Sacco Eye Group

Vestal, New York, United States

Site Status

Dept of Clinical Research, South Shore Eye Care, LLP

Wantagh, New York, United States

Site Status

Dunes Eye Consultants

Dakota Dunes, South Dakota, United States

Site Status

Total Eye Care

Memphis, Tennessee, United States

Site Status

University of Houston College of Optometry

Houston, Texas, United States

Site Status

William J Bogus, OD, FAAO

Salt Lake City, Utah, United States

Site Status

Center for Ocular Research & Education, School of Optometry, University of Waterloo School of Optometry & Vision Science

Waterloo, Ontario, Canada

Site Status

Countries

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United States Canada

References

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Rappon J, Chung C, Young G, Hunt C, Neitz J, Neitz M, Chalberg T. Control of myopia using diffusion optics spectacle lenses: 12-month results of a randomised controlled, efficacy and safety study (CYPRESS). Br J Ophthalmol. 2023 Nov;107(11):1709-1715. doi: 10.1136/bjo-2021-321005. Epub 2022 Sep 1.

Reference Type DERIVED
PMID: 36126105 (View on PubMed)

Other Identifiers

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CPRO-1802-001

Identifier Type: -

Identifier Source: org_study_id