Spectacle Lens Visual Acuity Assessments Study

NCT ID: NCT05650190

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

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-08

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myopia Myopia Progression Juvenile Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test Arm

Single vision, impact resistant spectacle lenses; Test Arm

Group Type EXPERIMENTAL

Novel spectacle lens design

Intervention Type DEVICE

Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia

Control Arm

Single vision, impact resistant spectacle lenses; Control Arm

Group Type PLACEBO_COMPARATOR

Spectacle lenses

Intervention Type DEVICE

Single vision, impact resistant spectacle lenses

Interventions

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Novel spectacle lens design

Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia

Intervention Type DEVICE

Spectacle lenses

Single vision, impact resistant spectacle lenses

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

14 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

Locations

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Sabal Eye Care

Longwood, Florida, United States

Site Status

Kannarr Eye Care

Pittsburg, Kansas, 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

Vision Optique

Houston, Texas, United States

Site Status

William J Bogus, OD, FAAO

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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CPRO-2209-001

Identifier Type: -

Identifier Source: org_study_id