MyopiaNCT07294404
Peripheral Relative Refractive Power of Orthokeratology Lenses
An observational study of Myopia and Myopia; Refractive Error, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
Orthokeratology (OK) has been demonstrated to be an effective intervention for slowing axial elongation in children with myopia. The proposed mechanism of action is the induction of peripheral myopic defocus, which reduces relative peripheral hyperopia on the retina. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Myopia; Refractive Error
- What is being tested?
- orthokeratology
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2020to 19 Oct 2021
- How long will I take part?
- 1 Year
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 8 to 15 years with myopia who are eligible for and fitted with orthokeratology lenses. Participants must demonstrate the ability to maintain adequate compliance with lens wear and follow-up requirements.
Who may be able to join
- 8 to 15 years old
- myopia of -4.00D or lower,
- regular astigmatism ≤1.50D and non-regular astigmatism ≤1.00D
- intraocular pressure ≤21mmHg
- understand the purpose of the study and have good hygiene and regular follow-up
Who cannot join
- unilateral
- immunocompromised subjects with systemic diseases (such as acute or chronic sinusitis, diabetes mellitus, Down syndrome, rheumatoid arthritis, psychiatric patients, etc.)
- complicated with other eye diseases that affect OK lens wearing, such as dacryocystitis, blepharitis and other inflammation, glaucoma, etc.
- BCVA less than 1.0
- children with corneal curvature less than 40.00D or higher than 46.00D.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Orthokeratology and Peripheral Retinal Refraction Changes
Orthokeratology (OK) has been demonstrated to be an effective intervention for slowing axial elongation in children with myopia. The proposed mechanism of action is the induction of peripheral myopic defocus, which reduces relative peripheral hyperopia on the retina.
This study aims to evaluate changes in relative peripheral retinal refraction before and after OK lens wear using wide-field multispectral retinal refractive topography. The study will also investigate the relationship between these retinal refractive changes and the effectiveness of OK in controlling axial elongation.
- Conditions
- Myopia, Myopia; Refractive Error
- Being tested
- orthokeratology
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthokeratologyDevice
All participants will be fitted with orthokeratology lenses of the same design. The primary objective is to assess changes in relative peripheral retinal refraction before and after lens wear.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in axial length growth(ALG)
Axial length will be measured using an ocular biometer (AL-Scan, NIDEK, Japan). Axial length growth (ALG) will be defined as the difference between the 1-year measurement and baseline.
Measured: Change from baseline in axial length at 12 months
Secondary outcomes (1)
Change in Relative Peripheral Retinal Refraction
Retinal refractive power will be measured using multispectral retinal refractive topography. Relative peripheral retinal refraction will be calculated as the difference between peripheral and central retinal refractive power. Changes from pre- to post-orthokeratology lens wear will be evaluated.
Measured: Baseline (pre-lens wear), 1 month, 6 months, and 12 months after orthokeratology lens wear.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start10 Jan 2020
- Primary completion15 Jun 2021
- Study completion19 Oct 2021
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
- Other
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294404
- Sponsor's protocol ID
- OK RPR
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Orthokeratology and Peripheral Retinal Refraction Changes
- ClinicalTrials.gov ID
- NCT07294404
- Acronym / sponsor ID
- OK RPR
- Conditions
- Myopia, Myopia; Refractive Error
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 19 Dec 2025 (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.
Orthokeratology (OK) has been demonstrated to be an effective intervention for slowing axial elongation in children with myopia. The proposed mechanism of action is the induction of peripheral myopic defocus, which reduces relative peripheral hyperopia on the retina.
This study aims to evaluate changes in relative peripheral retinal refraction before and after OK lens wear using wide-field multispectral retinal refractive topography. The study will also investigate the relationship between these retinal refractive changes and the effectiveness of OK in controlling axial elongation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 8 to 15 years with myopia who are eligible for and fitted with orthokeratology lenses. Participants must demonstrate the ability to maintain adequate compliance with lens wear and follow-up requirements.
Key inclusion criteria (5 listed)
- 8 to 15 years old
- myopia of -4.00D or lower,
- regular astigmatism ≤1.50D and non-regular astigmatism ≤1.00D
- intraocular pressure ≤21mmHg
- understand the purpose of the study and have good hygiene and regular follow-up
Key exclusion criteria (5 listed)
- unilateral
- immunocompromised subjects with systemic diseases (such as acute or chronic sinusitis, diabetes mellitus, Down syndrome, rheumatoid arthritis, psychiatric patients, etc.)
- complicated with other eye diseases that affect OK lens wearing, such as dacryocystitis, blepharitis and other inflammation, glaucoma, etc.
- BCVA less than 1.0
- children with corneal curvature less than 40.00D or higher than 46.00D.
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 |
|---|---|---|
| orthokeratologyAll participants will be fitted with orthokeratology lenses of the same design. The primary objective is to assess changes in relative peripheral retinal refraction before and after lens wear. | Device | – |
Primary outcome
Changes in axial length growth(ALG)
Time frame: Change from baseline in axial length at 12 months
Axial length will be measured using an ocular biometer (AL-Scan, NIDEK, Japan). Axial length growth (ALG) will be defined as the difference between the 1-year measurement and baseline.
1 secondary outcome
Change in Relative Peripheral Retinal Refraction
Time frame: Baseline (pre-lens wear), 1 month, 6 months, and 12 months after orthokeratology lens wear.
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 2 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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 Myopia and Myopia; Refractive Error, 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 5 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: finished, as of the sponsor's last update on 2 Mar 2026. 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?
Changes in axial length growth(ALG) (time frame: Change from baseline in axial length at 12 months). 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 2 Mar 2026.