Clinical trial NCT06185868: Clinical Research Plan for Human Myopia Models
Official title: Clinical Research Plan for Human Myopia Models
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Myopia Model
Lead sponsor: Robotrak Technologies Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruited volunteers

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.

Eligibility criteria: 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

Primary outcomes:
measure: Refraction
timeFrame: 7 months
measure: Whole eye aberration
timeFrame: 7 months
measure: Pupil diameter
timeFrame: 7 months
measure: Eye axis length
timeFrame: 7 months
measure: Corneal anterior and posterior surface curvature
timeFrame: 7 months
measure: Corneal thickness
timeFrame: 7 months
measure: Anterior Chamber Depth
timeFrame: 7 months
measure: Corrected Visual Acuity
timeFrame: 7 months
measure: Intraocular Pressure
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Robotrak Technologies Co., Ltd.
Study officials:
References: