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NCT07839091
Comparing Myopia Control Spectacle Lenses and Standard Single Vision Spectacle Lenses in Children With Myopia
Conditions: Myopia, Myopia Progression
Sex: All
Ages: 6 Years – 10 Years
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Essilor International
Location: Essilor R&D Centre Singapore Singapore
Summary
The purpose of this clinical trial is to compare a new myopia control spectacle lens with a standard single vision spectacle lens in slowing the progression of myopia (nearsightedness) in healthy children aged 6 to under 11 years.
The main question being studied is:
Is the new myopia control spectacle lens more effective than a standard single vision spectacle lens in slowing myopia progression?
In this study, participants will wear a myopia control spectacle lens in one eye and a standard single vision spectacle lens in the other eye for the first 6 months. The lens assignment will then be switched between eyes for the remaining 6 months. Researchers will compare changes in eye axial length and refractive error between the two lens types.
Participants will:
* Wear the study spectacles for 12 months.
* Attend scheduled follow-up visits at the Essilor R\&D Centre, Singapore.
Eligibility Criteria
Inclusion Criteria:
1. Volunteer participant with the willingness and ability to comply with all scheduled study visits.
2. Informed consent of parent/guardian and assent of participant.
3. Age equal to or greater than 6 years and less than 11 years (before 11th birthday) at the time of consent.
4. Spherical equivalent refraction (SER) equal or less than -0.50 D and equal or greater than -4.75D with astigmatism not more than 2.00 D.
5. Difference in SER (anisometropia) between two eyes should not exceed 1.00 D.
6. Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR under high contrast in each eye.
7. Be in good general health, based on the participant and the parent's/guardian's knowledge.
8. Agree to wear the study spectacles for 12 hours per day and 7 days per week.
9. Agree not to be involved in other myopia control treatments.
Exclusion Criteria:
1. History of Atropine, Orthokeratology, Myopia Control Contact Lens, or Red Light treatment.
2. Strabismus by cover test at near or distance wearing correction.
3. History and presence of amblyopia.
4. Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).
5. Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
6. History of ocular injury or surgery.
7. Participation in any clinical study within 30 days of the Baseline visit.
8. Current or anticipated use of growth hormones.
9. Study participants deemed inappropriate for the study by the investigator.
10. 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.
Source: ClinicalTrials.gov (NCT07839091). StuddyBuddy aggregates publicly available trial information.