BridgeMD
New treatment option for Myopia
Official title An Evaluation of Myopia Control Lenses on Wearing Experience in Myopic Children
ClinicalTrials.gov ID: NCT07354945
What this study is testing
- What it's testing
- The goal of this research study is to understand the wearing experience of A.M.L. series of lenses in myopic children.
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 12
You may be able to join if
- Volunteer participant
- Informed consent of parent/guardian and assent of participant
- Age equal to or greater than 6 years and not older than 12 years at the time of signing informed consent and assent
- Spherical equivalent refraction (SER) by cycloplegic autorefraction equal or less than -0.50 D and equal or greater than -4.75D with astigmatism not...
- Difference in SER (anisometropia) between two eyes should not exceed 1.50 D
You likely can't join if
- History of Atropine, Orthokeratology, or Red Light treatment
- Strabismus by cover test at near or distance wearing correction
- Amblyopia
- Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders...
- Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive...
- History of ocular injury or surgery
See the full eligibility criteria
- Volunteer participant
- Informed consent of parent/guardian and assent of participant
- Age equal to or greater than 6 years and not older than 12 years at the time of signing informed consent and assent
- Spherical equivalent refraction (SER) by cycloplegic autorefraction equal or less than -0.50 D and equal or greater than -4.75D with astigmatism not more than 2.00 D on both eye
- Difference in SER (anisometropia) between two eyes should not exceed 1.50 D
- Best corrected visual acuity (BCVA) better than or equal to +0.10 LogMAR in each eye
- Be in good general health, based on the participant and the parent's/guardian's knowledge
- Willingness and ability to participate in study and comply with all scheduled visits
- History of Atropine, Orthokeratology, or Red Light treatment
- Strabismus by cover test at near or distance wearing correction
- Amblyopia
- Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.)
- Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state
- History of ocular injury or surgery
- Participation in any clinical study within 30 days of the Baseline visit
- Study participants deemed inappropriate for the study by the investigator
- The inherent ocular/systemic discomfort (dry eyes, visual fatigue, headaches, etc.) that may affect the evaluation of the study lens wearing experience, from the investigator's perspective
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
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 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. 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.