Clinical Research Plan for Human Myopia Models

Completed

• Conditions: Human Myopia Model

• Registration Number: NCT06185868
• Lead Sponsor: Robotrak Technologies Co., Ltd.

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.

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 Timeline

• Study Start: 2022-05-01
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-15
• Last Update Submitted: 2023-12-15
• Study First Posted: 2023-12-29
• Last Update Posted: 2023-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Whole eye aberration	7 months	Units of measurement:micorn; measurement tool: Visual quality analyzer;
Refraction	7 months	Units of measurement:Diopter; measurement tool: subjective refraction;
Pupil diameter	7 months	Units of measurement:millimetre; measurement tool Visual quality analyzer;
Corrected Visual Acuity	7 months	Units of measurement:NA; measurement tool: subjective refraction;
Eye axis length	7 months	Units of measurement:millimetre; measurement tool: IOLMaster 700(ZEISS)
Corneal anterior and posterior surface curvature	7 months	Units of measurement:Diopter; measurement tool: Petacam HR
Intraocular Pressure	7 months	Units of measurement:millimeters of mercury height; measurement tool: Tonometer (NT-510)
Corneal thickness	7 months	Units of measurement:millimetre; measurement tool: Petacam HR
Anterior Chamber Depth	7 months	Units of measurement:millimetre; measurement tool: Petacam HR

Trial Locations

Locations (1)

Robotrak Technologies Co., Ltd.; 🇨🇳 Nanjing, China