Crossover RCT of TAMER Lenses in Myopia Control

Launched by SHANGHAI EYE DISEASE PREVENTION AND TREATMENT CENTER · Mar 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a special type of glasses called TAMER lenses in controlling myopia, which is also known as nearsightedness, in children. The researchers want to find out how well these lenses work compared to regular single vision lenses in slowing down the progression of myopia. The study aims to include 120 Chinese children aged 6 to 12 years who do not have any serious eye or health issues. To participate, children should have a specific level of nearsightedness and be willing to wear the glasses provided during the study.

Participants in the trial will be randomly assigned to wear either the TAMER lenses or regular lenses for a certain period, and then they will switch to the other type of lens. Throughout the study, researchers will monitor changes in their vision to see how well each type of lens helps with myopia control. It’s important to note that children with certain eye conditions, recent treatments for myopia, or other health issues may not be eligible to join. Parents or guardians must also help with the consent process to ensure the child understands what being part of the study entails.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Race: Chinese children and adolescents.
• • Age 6-12 years, gender unrestricted.
• • Cycloplegic refraction SER: -0.75DS\~-5.0DS in both eyes.
• • Best corrected visual acuity of both eyes reaches 0.8 (0.00 logMAR).
• • Cylinder power and astigmatism are no more than 1.5D.
• • During the study period, willing to wear glasses provided by the researcher only and without additional interventions.
• • Willing to be randomly assigned.
• • Able to sign an informed consent form with the accompaniment and understanding of parents or guardians.
• Exclusion Criteria:
• • Allergic or intolerant to medications used for cycloplegia.
• • Received any nearsightedness treatment such as atropine, rigid gas permeable contact lens, bifocal/progressive lens, red light therapy, or acupuncture within half a year before the study.
• • Diagnosed with any eye disease other than nearsightedness, including strabismus, corneal diseases, conjunctival or eyelid damage or other conditions (such as keratoconus, herpes simplex keratitis, etc.).
• • History of eye surgery (including strabismus correction surgery).
• • Eye or systemic diseases that might be associated with nearsightedness or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.
• • Anatomical or dermatological factors that may interfere with the wearing of spectacle frames.
• • Other reasons that the researcher deems inappropriate for the participant to be included in the study, such as excessively high expectations for the effectiveness of defocus lenses, or plans to use other nearsightedness intervention strategies simultaneously with the study.