S.T.O.P.® Technology Contact Lenses Versus Dual-focus Contact Lenses for Slowing Down Myopia Prog… (NCT05243836) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
S.T.O.P.® Technology Contact Lenses Versus Dual-focus Contact Lenses for Slowing Down Myopia Progression in Children
China, India, Spain441 participantsStarted 2023-08-04
Plain-language summary
To compare the rate of myopia progression of contact lenses utilising S.T.O.P.® technology against MiSight® contact lenses.
Who can participate
Age range8 Years – 14 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be between 8-14.
* Have:
* Read the Informed Assent.
* Been explained the Informed Assent.
* Indicated an understanding of the Informed Assent.
* Signed the Informed Assent.
* Have their parent / legal guardian:
* Read the Informed Consent.
* Been explained the Informed Consent.
* Indicated an understanding of the Informed Consent.
* Signed the Informed Consent.
* Along with their parent / legal guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to study requirements.
* Along with their parent / legal guardian, agree to maintain the visit schedule .
* Agree to wear allocated contact lenses for a minimum of 5 days per week, at least 6 hours per day on days lenses are worn but not \> 16 hours per day, and to remove lenses at night (i.e., daily wear only with no contact lens wear during sleep), for their duration of the study and to inform the investigator if their schedule is interrupted. Wearing time can be modified by the investigator for health reasons.
* Possess wearable and visually functioning spectacles.
* Be in good general health, based on the parent's / legal guardian's knowledge.
* Have best-corrected high contrast visual acuity based on manifest refraction of 0.10 logMAR (20/25, 6/7.6) or better in each eye.
* Meet the following criteria determined by cycloplegic autorefraction:
* Spherical equivalent between -0.75 to -4.00 D inclusive.
* Astigmatism ≥ -1.00 D.
\*partici…