MyopiaNCT05956717
The Effect of Orthokeratography on the Quality of Life and Behavior of Myopic Children
An observational study of Myopia, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
The study intended to observe the changes in the quality of life, behavior, and eye habits of children and adolescents aged 8-18 years before and after orthokeratology, as well as the differences in the quality of life and behaviors of different myopic groups after keratoplasty, using the EQ-5D-Y, CHU9D, and CHROME-G… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Myopia
- What is being tested?
- Orthokeratology
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Oct 2024
- 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 8 to 18 years
- All sexes
- Child, Adult
Study population: Adolescents aged 8-18 years with normal eye health
Who may be able to join
- Spherical equivalent ranged -1.00D from-5.00D
- Optimal corrected visual acuity ≥1.0 in both eyes
- No apparent strabismus or other eye disease
- Able to read Chinese and communicate in Mandarin, able to understand the questions in the questionnaire
Who cannot join
- A history of corneal surgery within 1 year
- Eyelid abnormalities or infection
- An inability to wear orthokeratology
- Use medications that affect the wear of eye and corneal contact lenses
- Those who have participated in a clinical trial of a drug within 90 days
- Allergic patients who have used contact lenses and/or care products
- The researchers consider it inappropriate to participate in this program
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Eye Hospital
Tianjin, 300020
Shuang yin, MD, +8627306525, yins2020@126.com
About this study
The study intended to observe the changes in the quality of life, behavior, and eye habits of children and adolescents aged 8-18 years before and after orthokeratology, as well as the differences in the quality of life and behaviors of different myopic groups after keratoplasty, using the EQ-5D-Y, CHU9D, and CHROME-G scales with the use of a self-assessment method.
- Conditions
- Myopia
- Being tested
- Orthokeratology
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthokeratologyDevice
The experimental group wore orthokeratology lenses
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Subjects wore orthokeratology lenses Receives: Device: Orthokeratology | |
| Control group | Subjects wore single-vision glasses group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in EuroQol five dimensions questionnaire(EQ-5D-Y) score
The health utility can be calculated by the number of the answer to the question. 0 means death and 1means complete health.
Measured: The change was the difference between each two follow-up times, including before and one day, one week, one month and three months after orthokeratology
Changes in the Child Health Utility 9D (CHU9D) score
The health utility can be calculated by the number of the answer to the question. 0 means death and 1means complete health.
Measured: The change was the difference between each two follow-up times, including before and one day, one week, one month and three months after orthokeratology
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956717
- Sponsor's protocol ID
- KY2023032
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Orthokeratography on the Quality of Life and Behavior of Myopic Children
- ClinicalTrials.gov ID
- NCT05956717
- Acronym / sponsor ID
- KY2023032
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 21 Jul 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.
The study intended to observe the changes in the quality of life, behavior, and eye habits of children and adolescents aged 8-18 years before and after orthokeratology, as well as the differences in the quality of life and behaviors of different myopic groups after keratoplasty, using the EQ-5D-Y, CHU9D, and CHROME-G scales with the use of a self-assessment method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Device: OrthokeratologySubjects wore orthokeratology lenses |
| Control group | – | –Subjects wore single-vision glasses group |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Adolescents aged 8-18 years with normal eye health
Key inclusion criteria (4 listed)
- Spherical equivalent ranged -1.00D from-5.00D
- Optimal corrected visual acuity ≥1.0 in both eyes
- No apparent strabismus or other eye disease
- Able to read Chinese and communicate in Mandarin, able to understand the questions in the questionnaire
Key exclusion criteria (7 listed)
- A history of corneal surgery within 1 year
- Eyelid abnormalities or infection
- An inability to wear orthokeratology
- Use medications that affect the wear of eye and corneal contact lenses
- Those who have participated in a clinical trial of a drug within 90 days
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 |
|---|---|---|
| OrthokeratologyThe experimental group wore orthokeratology lenses | Device | Experimental Group |
Primary outcome
Changes in EuroQol five dimensions questionnaire(EQ-5D-Y) score
Time frame: The change was the difference between each two follow-up times, including before and one day, one week, one month and three months after orthokeratology
The health utility can be calculated by the number of the answer to the question. 0 means death and 1means complete health.
Changes in the Child Health Utility 9D (CHU9D) score
Time frame: The change was the difference between each two follow-up times, including before and one day, one week, one month and three months after orthokeratology
The health utility can be calculated by the number of the answer to the question. 0 means death and 1means complete health.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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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.
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 Myopia, run by Tianjin Eye Hospital 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shuang yin, MD (+8627306525, yins2020@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in EuroQol five dimensions questionnaire(EQ-5D-Y) score (time frame: The change was the difference between each two follow-up times, including before and one day, one week, one month and three months after orthokeratology). The study lists 2 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 21 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.