Clinical Research Plan for Human Myopia Models

NCT06185868 | Completed

• 1 other identifier: RYMX202201
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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 children and adolescents.

Conditions

Human Myopia Model

Outcome Measures

Primary Outcomes (9)

• Refraction

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

  7 months

• Whole eye aberration

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

  7 months

• Pupil diameter

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

  7 months

• Eye axis length

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

  7 months

• Corneal anterior and posterior surface curvature

  Units of measurement:Diopter; measurement tool: Petacam HR

  7 months

• Corneal thickness

  Units of measurement:millimetre; measurement tool: Petacam HR

  7 months

• Anterior Chamber Depth

  Units of measurement:millimetre; measurement tool: Petacam HR

  7 months

• Corrected Visual Acuity

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

  7 months

• Intraocular Pressure

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

  7 months

Interventions

No intervention measures OTHER

No intervention measures

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Recruited volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• Robotrak Technologies Co., Ltd.: lead

Study Sites (1)

Robotrak Technologies Co., Ltd.

Nanjing, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples Without DNA

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 29, 2023
• Study Start: May 1, 2022
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: December 29, 2023

Record last verified: 2023-12

Locations

CN (1)