Myopia, Progressive
Conditions
Brief summary
This study is a prospective, randomized, crossover clinical trial with a planned proposed enrollment of 120 Chinese male and female subjects aged 6-12 years without systemic or ocular diseases to follow up their cycloplegic equivalent spherical lens power and other relevant indices in order to determine the role of TAMER lenses in myopia control as compared to singlie vision lenses.
Interventions
DEVICETAMER Lens Spectacle
Regular daily wear of TAMER lens spectacle
DEVICESV lenses
SV lenses
Sponsors
Shanghai Eye Disease Prevention and Treatment Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spherical Equivalent change | 6 months | cycloplegic SE change |
Secondary
| Measure | Time frame |
|---|---|
| Axial Length change | 6 months |
| Spherical Equivalent change | 12 months |
Countries
China
Contacts
Primary ContactXiangui He
Outcome results
None listed