Status:

COMPLETED

Clinical Research Plan for Human Myopia Models

Lead Sponsor:

Robotrak Technologies Co., Ltd.

Conditions:

Human Myopia Model

Eligibility:

All Genders

6-16 years

Brief Summary

Collect optical biological parameters, refractive index data, and other related parameters of myopia and refractive errors in children and adolescents, and establish an optical model of myopia in chil...

Detailed Description

Experimental research purpose:Collect optical biological parameters, refractive index data, and other related parameters of myopia and refractive errors in children and adolescents, and establish an o...

Eligibility Criteria

Inclusion

  • Selection criteria:
  • Gender unlimited
  • Age 6-16 years old
  • Through medical optometry with dilated pupils, the spherical equivalent refractive index is within the range of -0.5DS\~-8.0DS, and the cylindrical lens is ≤ -0.75DC
  • Exclusion criteria:
  • Patients with corneal diseases such as corneal ulcers, corneal opacities, and corneal leukoplakia
  • Patients with refractive media opacity, such as cataracts and vitreous hemorrhage
  • Glaucoma patients
  • Patients with nystagmus
  • Patients with strabismus and amblyopia
  • Patients with fundus diseases
  • Patients with a column mirror range greater than -0.75DC
  • Patients with binocular anisometropia ≥ 1.0D
  • Corneal contact lenses (such as corneal reshaping lenses, multifocal contact lenses, and RGP) with a history of wearing
  • Long term history of low concentration atropine and other ocular medications
  • Wearing history of functional lenses such as asymptotic multifocal, multi-point myopic defocus, peripheral defocus, etc
  • Patients participating in other eye clinical trials
  • Individuals with mental illness or cognitive impairment who are unable to cooperate
  • Researchers believe that other reasons are not suitable for clinical trial participants, such as poor physical condition on the day of the trial

Exclusion

    Key Trial Info

    Start Date :

    May 1 2022

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    October 30 2022

    Estimated Enrollment :

    2000 Patients enrolled

    Trial Details

    Trial ID

    NCT06185868

    Start Date

    May 1 2022

    End Date

    October 30 2022

    Last Update

    December 29 2023

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Robotrak Technologies Co., Ltd.

    Nanjing, China