BridgeMD
Tests treatment safety and results for Myopia
Official title Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
ClinicalTrials.gov ID: NCT06034327
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 8. Healthy volunteers may be eligible.
You may be able to join if
- Children 6 - 8 years of age (inclusive) at time of informed consent/assent;
- Spherical equivalent refractive error between -0.75 and -4.50 D inclusive (by manifest refraction) in each eye;
- Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in each eye;
- Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye;
- 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;
You likely can't join if
- Subject has previously or currently wears contact lenses (greater than 1-month usage);
- Current or prior use of bifocals, progressive addition spectacle lenses
- Current or prior use of any myopia control treatment (e.g., atropine, multifocal contact lenses, orthokeratology);
- Amblyopia in either eye;
- Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction;
- Any ocular or systemic conditions that could influence refractive development or status [e.g., keratoconus, congenital glaucoma, ocular trauma...
See the full eligibility criteria
- Children 6 - 8 years of age (inclusive) at time of informed consent/assent;
- Spherical equivalent refractive error between -0.75 and -4.50 D inclusive (by manifest refraction) in each eye;
- Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in each eye;
- Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye;
- 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;
- 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);
- 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;
- Willingness to participate in the trial for 24 months without contact lens wear;
- 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.
- Subject has previously or currently wears contact lenses (greater than 1-month usage);
- Current or prior use of bifocals, progressive addition spectacle lenses
- Current or prior use of any myopia control treatment (e.g., atropine, multifocal contact lenses, orthokeratology);
- Amblyopia in either eye;
- Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction;
- 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...
- Known allergy to proparacaine, tetracaine, or tropicamide;
- Participation in any investigational clinical study within 30 days of the Baseline visit;
- Subject's sibling or other household member is already enrolled in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Oakland, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Santa Ana, California, United States
- Longwood, Florida, United States
- Marietta, Georgia, United States
- Chicago, Illinois, United States
- Pittsburg, Kansas, United States
- Boston, Massachusetts, United States
- Raytown, Missouri, United States
- Athens, Ohio, United States
- Granville, Ohio, United States
- Beaumont, Texas, United States
- Bellaire, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 8 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oakland, California, United States; San Diego, California, United States; San Francisco, California, United States; Santa Ana, California, United States; Longwood, Florida, United States; Marietta, Georgia, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.