Using TAMER lenses to control myopia in children

A Randomized, Crossover Controlled Trial of the Effect of TAMER Lenses Versus Single Vision Lenses on Myopic Progression in Myopic Children

This study is testing if special TAMER lenses can help control worsening nearsightedness in children aged 6 to 12 better than regular lenses.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 6 Years to 12 Years
• Sex: All
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06329986 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, randomized, crossover study aimed at evaluating the effectiveness of TAMER lenses in controlling myopia in children aged 6-12 years. The study plans to enroll 120 participants who will be followed to assess changes in their cycloplegic equivalent spherical lens power and other relevant indices. Participants will be randomly assigned to wear either TAMER lenses or single vision lenses during different phases of the trial. The goal is to determine how well TAMER lenses perform compared to traditional lenses in managing progressive myopia.

Who should consider this trial

Good fit: Ideal candidates are Chinese children aged 6-12 years with mild to moderate myopia.

Not a fit: Patients with other eye diseases or those who have recently undergone myopia treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new lens option for better control of myopia progression in children.

How similar studies have performed: While there have been studies on myopia control, the specific use of TAMER lenses in this context is novel and has not been extensively tested.

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.

Where this trial is running

Shanghai, Shanghai

• Shanghai Eye Disease Prevention and Treatment Center — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Xiangui He

Conditions Myopia; Progressive