Crossover RCT of TAMER Lenses in Myopia Control

Last updated: March 25, 2024
Sponsor: Shanghai Eye Disease Prevention and Treatment Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopia

Treatment

TAMER Lens Spectacle

SV lenses

Clinical Study ID

NCT06329986
SEDPTC20240109
  • Ages 6-12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andwithout 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 cycloplegia.
  • Received any nearsightedness treatment such as atropine, rigid gas permeable contactlens, bifocal/progressive lens, red light therapy, or acupuncture within half a yearbefore the study.
  • Diagnosed with any eye disease other than nearsightedness, including strabismus,corneal diseases, conjunctival or eyelid damage or other conditions (such askeratoconus, 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 of spectacleframes.
  • Other reasons that the researcher deems inappropriate for the participant to beincluded in the study, such as excessively high expectations for the effectiveness ofdefocus lenses, or plans to use other nearsightedness intervention strategiessimultaneously with the study.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: TAMER Lens Spectacle
Phase:
Study Start date:
February 24, 2024
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • Shanghai Eye Disease Prevention and Treatment Center

    Shanghai, Shanghai 200041
    China

    Active - Recruiting

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