Human Myopia ModelNCT06185868
Clinical Research Plan for Human Myopia Models
An observational study of Human Myopia Model, run by Robotrak Technologies Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Myopia Model
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Recruited volunteers
Who may be able to join
None listed.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Human Myopia Model
- Being tested
- No intervention measures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention measuresOther
No intervention measures
What is being measured
The primary outcome is the main question the study is designed to answer.
Refraction
Units of measurement:Diopter; measurement tool: subjective refraction;
Measured: 7 months
Whole eye aberration
Units of measurement:micorn; measurement tool: Visual quality analyzer;
Measured: 7 months
Pupil diameter
Units of measurement:millimetre; measurement tool Visual quality analyzer;
Measured: 7 months
Eye axis length
Units of measurement:millimetre; measurement tool: IOLMaster 700(ZEISS)
Measured: 7 months
Corneal anterior and posterior surface curvature
Units of measurement:Diopter; measurement tool: Petacam HR
Measured: 7 months
Corneal thickness
Units of measurement:millimetre; measurement tool: Petacam HR
Measured: 7 months
Anterior Chamber Depth
Units of measurement:millimetre; measurement tool: Petacam HR
Measured: 7 months
Corrected Visual Acuity
Units of measurement:NA; measurement tool: subjective refraction;
Measured: 7 months
Intraocular Pressure
Units of measurement:millimeters of mercury height; measurement tool: Tonometer (NT-510)
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 May 2022
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Myopia ModelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robotrak Technologies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185868
- Sponsor's protocol ID
- RYMX202201
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Plan for Human Myopia Models
- ClinicalTrials.gov ID
- NCT06185868
- Acronym / sponsor ID
- RYMX202201
- Conditions
- Human Myopia Model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Robotrak Technologies Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Recruited volunteers
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention measuresNo intervention measures | Other | – |
Primary outcome
Refraction
Time frame: 7 months
Units of measurement:Diopter; measurement tool: subjective refraction;
Whole eye aberration
Time frame: 7 months
Units of measurement:micorn; measurement tool: Visual quality analyzer;
Pupil diameter
Time frame: 7 months
Units of measurement:millimetre; measurement tool Visual quality analyzer;
Eye axis length
Time frame: 7 months
Units of measurement:millimetre; measurement tool: IOLMaster 700(ZEISS)
Corneal anterior and posterior surface curvature
Time frame: 7 months
Units of measurement:Diopter; measurement tool: Petacam HR
Corneal thickness
Time frame: 7 months
Units of measurement:millimetre; measurement tool: Petacam HR
Anterior Chamber Depth
Time frame: 7 months
Units of measurement:millimetre; measurement tool: Petacam HR
Corrected Visual Acuity
Time frame: 7 months
Units of measurement:NA; measurement tool: subjective refraction;
Intraocular Pressure
Time frame: 7 months
Units of measurement:millimeters of mercury height; measurement tool: Tonometer (NT-510)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Myopia Model, run by Robotrak Technologies Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refraction (time frame: 7 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.