Skip to main content
OpenTrials
Completed

NCT Number: NCT06185868

Clinical Research Plan for Human Myopia Models

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 children and adolescents.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Human Myopia Model

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Robotrak Technologies Co., Ltd.

Nanjing, China

About this study

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 optical model of myopia in children and adolescents.

Case selection: This study requires the inclusion of children and adolescents aged between 4 and 18 years who have been diagnosed with myopia and refractive errors through medical examination of dilated pupils.

Plan: Collect eye parameters such as refractive power, whole eye aberration, corrected visual acuity, pupil diameter, axial length, anterior and posterior corneal surface curvature, and corneal thickness of all subjects under 9 non dilated stimuli.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention measures

Other

No intervention measures

Primary outcomes

  1. Refraction

    Time frame: 7 months

    Units of measurement:Diopter; measurement tool: subjective refraction;

  2. Whole eye aberration

    Time frame: 7 months

    Units of measurement:micorn; measurement tool: Visual quality analyzer;

  3. Pupil diameter

    Time frame: 7 months

    Units of measurement:millimetre; measurement tool Visual quality analyzer;

  4. Eye axis length

    Time frame: 7 months

    Units of measurement:millimetre; measurement tool: IOLMaster 700(ZEISS)

  5. Corneal anterior and posterior surface curvature

    Time frame: 7 months

    Units of measurement:Diopter; measurement tool: Petacam HR

  6. Corneal thickness

    Time frame: 7 months

    Units of measurement:millimetre; measurement tool: Petacam HR

  7. Anterior Chamber Depth

    Time frame: 7 months

    Units of measurement:millimetre; measurement tool: Petacam HR

  8. Corrected Visual Acuity

    Time frame: 7 months

    Units of measurement:NA; measurement tool: subjective refraction;

  9. Intraocular Pressure

    Time frame: 7 months

    Units of measurement:millimeters of mercury height; measurement tool: Tonometer (NT-510)

Sponsors and collaborators

Lead sponsor

Robotrak Technologies Co., Ltd.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2023
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.