MyopiaNCT05090592
Influence of Corneal Biomechanical Properties on Myopia Control
An observational study of Myopia, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
to analyze the changes in corneal biomechanics of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) and explore the possible mechanism of myopia control Read more about this study
- Who is it for?
- Ages 8 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- orthokeratology and 0.01 atropine
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2021to 31 Dec 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 8 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: We enroll the clinical patient who recieved orthokeratology or 0.01% atropine for myopia control. Age limits was 8 to 20 year-old. The purpose and process were carefully addressed to the subjects and their guardians who signed an informed consent form before commencing this study.
Who may be able to join
- myopia (<-1D)
- received Orthokeratology or 0.01% atropine for myopia control
- regular follow-up
Who cannot join
- ocular surface disease( dry eye, keratoconus..)
- allergy to orthokeratology or atropine
- received eye surgery
- strabismus
- premature birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Corneal Biomechanical Properties on Myopia Reduction and Axial Elongation in Children Using Orthokeratology and 0.01% Atropine
to analyze the changes in corneal biomechanics of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) and explore the possible mechanism of myopia control
Read the detailed description
High myopia is accompanied by excessive growth of eyeball, which leads to many complications. Myopia control is a great concern of the government and ophthalmologists worldwide.
Atropine eye drops is used clinically to control the progression of myopia. In recent years, low dose Atropine eye drops (0.01%, 0.05% and 0.1%) have been proven to be effective in slowing growth of eyeball. With less negative effects, these eye drops have been widely used for school children in Taiwan. Orthokeratology is another effective tool to control myopia, and long-term wearing of Ortho-k lens can inhibit the speed of eyeball growth, it is the most useful optical treatment for myopia control.
The Corvis® ST is a combination of an air pulse tonometer with an ultra-high-speed Scheimpflug camera. The movement of the cornea is mainly influenced by three factors which can be measured by the instrument:
Intraocular pressure (IOP)，biomechanical properties of the cornea and corneal thickness. The relationship between adult corneal biomechanics and refractive error has been noted in recent years. Previous studies pointed out that corneal biomechanics analyzer (Corvis ST) can measure the deformation process of the cornea and the biomechanics parameters. These literature found that the corneas of myopic patients， esp. high myopic, have larger corneal deformation in biomechanics analysis and revealed that the corneal stiffness of myopia patients was lower. There are still few discussions about the effect of orthokeratology on corneal biomechanics and there is no research focused on the change of corneal biomechanics of low-concentration atropine user which is worthy of our further exploration.
In this study, the investigators hope to analyze the changes in corneal biomechanics of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) and explore the possible mechanism of myopia control.
- Conditions
- Myopia
- Being tested
- orthokeratology, 0.01 atropine
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthokeratologyDevice
orthokeratology wearing for myopia control
0.01 atropineDrug
0.01% atropine eye drop prevent myopic progression
| Study group | Role | What they receive |
|---|---|---|
| myopic children | Myopic children use overnight orthokeratology or 0.01% atropine eye drop per night for myopia control Receives: Device: orthokeratology; Drug: 0.01 atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of the intraocular pressure in myopic children with different treatment
the investigators measure the intraocular pressure(IOP, mmHg) of myopic children with different treatment (low concentration atropine eye drops and orthokeratology)
Measured: from the date of starting treatment, the IOP was measured 1 week, 1month and every 3 months up to 24 months.
changes of the visual acuity in myopic children with different treatment
the investigators measure the visual acuity of myopic children with different treatment (low concentration atropine eye drops and orthokeratology).
Measured: from the date of starting treatment, the visual acuity was measured 1 week, 1month and every 3 months up to 24 months.
changes of the central corneal thickness in myopic children with different treatment
the the investigators measure the central corneal thickness(CCT, micrometer, ㎛) of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) by Corvis ST machine
Measured: from the date of starting treatment, the central corneal thickness was measured 1 week, 1month and every 3 months up to 24 months.
changes of the corneal biomechanics index in myopic children with different treatment
the the investigators measure the corneal biomechanics index (CBI) of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) by Corvis ST machine
Measured: from the date of starting treatment, the corneal biomechanics index was measured 1 week, 1month and every 3 months up to 24 months.
changes of the stress-strain index in myopic children with different treatment
the the investigators measure the stress-strain index (SSI) of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) by Corvis ST machine
Measured: from the date of starting treatment, the stress-strain index (SSI) was measured 1 week, 1month and every 3 months up to 24 months.
Secondary outcomes (1)
changes of axial length in myopic children with different treatment
the investigators measure the axial length(mm) of eyeball of myopic children with different treatment (low concentration atropine eye drops and orthokeratology).
Measured: from the date of starting treatment, the axial length was measured, then repeat measure were performed every 6 months up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Jan 2021
- Primary completion30 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheng-Jen Chiu, Doctor, Study director, Tzu Chi genral hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090592
- Sponsor's protocol ID
- Buddhist TCGH
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Lee SH, Tsai PC, Chiu YC, Wang JH, Chiu CJ. Impact of orthokeratology and low-dose atropine on corneal biomechanics and myopia progression in children. Ophthalmic Physiol Opt. 2025 Mar;45(2):565-576. doi: 10.1111/opo.13446. Epub 2025 Jan 13.
PubMed 39803986
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Corneal Biomechanical Properties on Myopia Reduction and Axial Elongation in Children Using Orthokeratology and 0.01% Atropine
- ClinicalTrials.gov ID
- NCT05090592
- Acronym / sponsor ID
- Buddhist TCGH
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Oct 2021 (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.
to analyze the changes in corneal biomechanics of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) and explore the possible mechanism of myopia control
Detailed description
High myopia is accompanied by excessive growth of eyeball, which leads to many complications. Myopia control is a great concern of the government and ophthalmologists worldwide.
Atropine eye drops is used clinically to control the progression of myopia. In recent years, low dose Atropine eye drops (0.01%, 0.05% and 0.1%) have been proven to be effective in slowing growth of eyeball. With less negative effects, these eye drops have been widely used for school children in Taiwan. Orthokeratology is another effective tool to control myopia, and long-term wearing of Ortho-k lens can inhibit the speed of eyeball growth, it is the most useful optical treatment for myopia control.
The Corvis® ST is a combination of an air pulse tonometer with an ultra-high-speed Scheimpflug camera. The movement of the cornea is mainly influenced by three factors which can be measured by the instrument:
Intraocular pressure (IOP)，biomechanical properties of the cornea and corneal thickness. The relationship between adult corneal biomechanics and refractive error has been noted in recent years. Previous studies pointed out that corneal biomechanics analyzer (Corvis ST) can measure the deformation process of the cornea and the biomechanics parameters. These literature found that the corneas of myopic patients， esp. high myopic, have larger corneal deformation in biomechanics analysis and revealed that the corneal stiffness of myopia patients was lower. There are still few discussions about the effect of orthokeratology on corneal biomechanics and there is no research focused on the change of corneal biomechanics of low-concentration atropine user which is worthy of our further exploration.
In this study, the investigators hope to analyze the changes in corneal biomechanics of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) and explore the possible mechanism of myopia control.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| myopic children | – | Device: orthokeratology, Drug: 0.01 atropineMyopic children use overnight orthokeratology or 0.01% atropine eye drop per night for myopia control |
Who may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- We enroll the clinical patient who recieved orthokeratology or 0.01% atropine for myopia control. Age limits was 8 to 20 year-old. The purpose and process were carefully addressed to the subjects and their guardians who signed an informed consent form before commencing this study.
Key inclusion criteria (3 listed)
- myopia (<-1D)
- received Orthokeratology or 0.01% atropine for myopia control
- regular follow-up
Key exclusion criteria (5 listed)
- ocular surface disease( dry eye, keratoconus..)
- allergy to orthokeratology or atropine
- received eye surgery
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 |
|---|---|---|
| orthokeratologyorthokeratology wearing for myopia control | Device | myopic children |
| 0.01 atropine0.01% atropine eye drop prevent myopic progression | Drug | myopic children |
Primary outcome
changes of the intraocular pressure in myopic children with different treatment
Time frame: from the date of starting treatment, the IOP was measured 1 week, 1month and every 3 months up to 24 months.
the investigators measure the intraocular pressure(IOP, mmHg) of myopic children with different treatment (low concentration atropine eye drops and orthokeratology)
changes of the visual acuity in myopic children with different treatment
Time frame: from the date of starting treatment, the visual acuity was measured 1 week, 1month and every 3 months up to 24 months.
the investigators measure the visual acuity of myopic children with different treatment (low concentration atropine eye drops and orthokeratology).
changes of the central corneal thickness in myopic children with different treatment
Time frame: from the date of starting treatment, the central corneal thickness was measured 1 week, 1month and every 3 months up to 24 months.
the the investigators measure the central corneal thickness(CCT, micrometer, ㎛) of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) by Corvis ST machine
changes of the corneal biomechanics index in myopic children with different treatment
Time frame: from the date of starting treatment, the corneal biomechanics index was measured 1 week, 1month and every 3 months up to 24 months.
the the investigators measure the corneal biomechanics index (CBI) of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) by Corvis ST machine
changes of the stress-strain index in myopic children with different treatment
Time frame: from the date of starting treatment, the stress-strain index (SSI) was measured 1 week, 1month and every 3 months up to 24 months.
the the investigators measure the stress-strain index (SSI) of myopic children with different treatment (low concentration atropine eye drops and orthokeratology) by Corvis ST machine
1 secondary outcome
changes of axial length in myopic children with different treatment
Time frame: from the date of starting treatment, the axial length was measured, then repeat measure were performed every 6 months up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Derived from this study: PubMed 39803986Lee SH, Tsai PC, Chiu YC, Wang JH, Chiu CJ. Impact of orthokeratology and low-dose atropine on corneal biomechanics and myopia progression in children. Ophthalmic Physiol Opt. 2025 Mar;45(2):565-576. doi: 10.1111/opo.13446. Epub 2025 Jan 13.
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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.
Cheng-Jen Chiu, Doctor study director
Tzu Chi genral hospital
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 Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
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 3 inclusion and 5 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 25 Oct 2021. 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 Taiwan. 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?
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?
changes of the intraocular pressure in myopic children with different treatment (time frame: from the date of starting treatment, the IOP was measured 1 week, 1month and every 3 months up to 24 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05090592, which also lists 1 linked publication.
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 25 Oct 2021.