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.

Study Overview

• Status: Completed
• Conditions: Human Myopia Model
• Intervention / Treatment: Other: No intervention measures

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 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.

• Study Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• China
  • Nanjing, China
    • Robotrak Technologies Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Recruited volunteers

Description

Selection criteria:

1. Gender unlimited
2. Age 6-16 years old
3. 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:

1. Patients with corneal diseases such as corneal ulcers, corneal opacities, and corneal leukoplakia
2. Patients with refractive media opacity, such as cataracts and vitreous hemorrhage
3. Glaucoma patients
4. Patients with nystagmus
5. Patients with strabismus and amblyopia
6. Patients with fundus diseases
7. Patients with a column mirror range greater than -0.75DC
8. Patients with binocular anisometropia ≥ 1.0D
9. Corneal contact lenses (such as corneal reshaping lenses, multifocal contact lenses, and RGP) with a history of wearing
10. Long term history of low concentration atropine and other ocular medications
11. Wearing history of functional lenses such as asymptotic multifocal, multi-point myopic defocus, peripheral defocus, etc
12. Patients participating in other eye clinical trials

13. 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Robotrak Technologies Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: RYMX202201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No