RECRUITING

Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens

Conditions

Myopia Juvenile Myopia Myopia Progression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a conventional efficacy trial to validate the results from previous clinical trials for younger children; the 12-month efficacy results will be used to predict the 3-year treatment efficacy. This is a randomized, controlled (1:1), multisite, subject- and observer-masked, 2-arm parallel group study.

Official Title

Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens

Quick Facts

Study Start:2023-09-18

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06034327

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 8 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Children 6 - 8 years of age (inclusive) at time of informed consent/assent; 2. Spherical equivalent refractive error between -0.75 and -4.50 D inclusive (by manifest refraction) in each eye; 3. Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in each eye; 4. Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye; 5. The difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 1.50 D; 6. Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day); 7. Ability to comply with study procedures, including high and low contrast visual acuity, axial length, and cycloplegic autorefraction measurements taken for both eyes at the baseline visit; 8. Willingness to participate in the trial for 24 months without contact lens wear; 9. The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.	1. Subject has previously or currently wears contact lenses (greater than 1-month usage); 2. Current or prior use of bifocals, progressive addition spectacle lenses 3. Current or prior use of any myopia control treatment (e.g., atropine, multifocal contact lenses, orthokeratology); 4. Amblyopia in either eye; 5. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction; 6. Any ocular or systemic conditions that could influence refractive development or status \[e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)\]; 7. Known allergy to proparacaine, tetracaine, or tropicamide; 8. Participation in any investigational clinical study within 30 days of the Baseline visit; 9. Subject's sibling or other household member is already enrolled in this trial.

Inclusion Criteria

Exclusion Criteria

1. Children 6 - 8 years of age (inclusive) at time of informed consent/assent;
2. Spherical equivalent refractive error between -0.75 and -4.50 D inclusive (by manifest refraction) in each eye;
3. Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in each eye;
4. Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye;
5. The difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 1.50 D;
6. Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
7. Ability to comply with study procedures, including high and low contrast visual acuity, axial length, and cycloplegic autorefraction measurements taken for both eyes at the baseline visit;
8. Willingness to participate in the trial for 24 months without contact lens wear;
9. The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.

1. Subject has previously or currently wears contact lenses (greater than 1-month usage);
2. Current or prior use of bifocals, progressive addition spectacle lenses
3. Current or prior use of any myopia control treatment (e.g., atropine, multifocal contact lenses, orthokeratology);
4. Amblyopia in either eye;
5. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction;
6. Any ocular or systemic conditions that could influence refractive development or status \[e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)\];
7. Known allergy to proparacaine, tetracaine, or tropicamide;
8. Participation in any investigational clinical study within 30 days of the Baseline visit;
9. Subject's sibling or other household member is already enrolled in this trial.

Contacts and Locations

Study Contact

Jennifer S Hill, BS

CONTACT

678-361-4877

jhill@sightglassvision.com

Vanessa Tasso, MA, MBA

CONTACT

949-751-7039

vtasso@sightglassvision.com

Study Locations (Sites)

Elsa Pao, OD

Oakland, California, 94607

United States

Scripps Poway Eyecare

San Diego, California, 92131

United States

Pacific Rims Optometry

San Francisco, California, 94127

United States

Paje Optometric

Santa Ana, California, 92704

United States

Omega Vision Center

Longwood, Florida, 32779

United States

Marietta Eye Clinic

Marietta, Georgia, 30060

United States

Ilinois College of Optometry

Chicago, Illinois, 60616

United States

Kannarr Eye Care

Pittsburg, Kansas, 66762

United States

New England College of Optometry

Boston, Massachusetts, 02115

United States

Advanced Eyecare PC

Raytown, Missouri, 64133

United States

Athens Eye Care

Athens, Ohio, 45701

United States

Procare Vision Centers, Inc.

Granville, Ohio, 43023

United States

Texas State Optical - Dowlen

Beaumont, Texas, 77706

United States

Bellaire Family Eye Care

Bellaire, Texas, 77401

United States

Collaborators and Investigators

Sponsor: SightGlass Vision, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-18

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2023-09-18

Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

Myopia
Juvenile Myopia
Myopia Progression