Double Helix Design Defocus Lens Spectacle (RACE) for Myopia Control

Phase

N/A

Condition

Myopia

Treatment

Double Helix Design Defocus Lens Spectacle (RACE)

single-vision spetacle lens

Clinical Study ID

NCT05894382

20230421v1.3

Ages 6-13
All Genders

Study Summary

This study uses 1.585 double helix defocus lens PC lenses with a unique optical design that includes a globally coherent visible area and complementary left and right helices that can form clear images. In addition, the helical arrangement and reduced slit area can generate defocusing signals, inhibiting the development of myopia. Therefore, based on previous research, this study plans to evaluate the safety and effectiveness of 1.585 double helix defocus lens PC frame eyeglasses in controlling the progression of myopia in children and adolescents through a randomized controlled clinical trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Race: Chinese children and adolescents.
Age 6-13 years, gender unrestricted.
Cycloplegic refraction SER: -0.75DS~-5.0DS in both eyes.
Best corrected visual acuity of both eyes reaches 1.0 (0.00 logMAR 6/6).
Refractive astigmatism and astigmatism are no more than 1.5D.
During the study period, willing to wear glasses provided by the researcher only (>10 hours) and without additional interventions.
Willing to be randomly assigned.
Able to sign an informed consent form with the accompaniment and understanding ofparents or guardians.

Exclusion

Exclusion Criteria:

Allergic or intolerant to medications used for ciliary muscle paralysis.
Received any nearsightedness treatment such as atropine, rigid gas permeable contactlens, bifocal/progressive lens, red light therapy, or acupuncture within 30 daysbefore the study.
Received defocus lenses for nearsightedness treatment in the past.
Diagnosed with any eye disease other than nearsightedness, including strabismus (esotropia greater than 8 prism diopters or exotropia greater than 12 prismdiopters), corneal diseases, conjunctival or eyelid damage or other conditions (suchas keratoconus, herpes simplex keratitis, etc.).
History of eye surgery (including strabismus correction surgery).
Eye or systemic diseases that might be associated with nearsightedness or itsprogression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.
Anatomical or dermatological factors that may interfere with the wearing ofspectacle frames.
Other reasons that the researcher deems inappropriate for the participant to beincluded in the study, such as excessively high expectations for the effectivenessof defocus lenses, or plans to use other nearsightedness intervention strategiessimultaneously with the study.

Study Design