MyopiaNCT05956704
The Different Design of Orthokeratology
A study testing Orthokeratology with aspheric wide inversion zone design in the optical zone and Orthokeratology with traditional spherical design in the optical zone in people with Myopia, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
In this study, we intend to enroll orthokeratology subjects aged 8-18 years old with binocular myopia up to and including -4.00 D. They were randomly selected to wear both orthokeratology of different designs, one with an aspheric wide inversion zone design in the optical zone and the other with a traditional… Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Orthokeratology with aspheric wide inversion zone design in the optical zone and Orthokeratology with traditional spherical design in the optical zone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Jun 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The age is greater than 8 years and less than 18 years
- The myopia was within -4.00D (including -4.00D), and the astigmatism was within 1.50D (including 1.50D) in both eyes.
- Be able to complete 12 months of follow-up
- They were able to understand the purpose of the trial, volunteered to participate, and signed informed consent by the subjects themselves or their legal guardians
Who cannot join
- One eye met the inclusion criteria
- Patients with systemic diseases causing immunocompromised or affecting orthokeratology
- There are other eye diseases that affect orthokeratology lens wearing, such as dacryocystitis, blepharitis, various inflammation, glaucoma, etc
- Abnormal cornea
- Previous corneal surgery or corneal trauma history
- Active keratitis (e.g., corneal infection)
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- Patients with best corrected distance visual acuity of less than 5.0
- Patients with corneal flat curvature lower than 39.00D, or higher than 48.00D
- Patients with refractive instability
- Patients with overt strabismus
- The corneal epithelium showed obvious fluorescent staining, which was not suitable for patients wearing orthokeratology lenses
- Patients with dry eye are not suitable for orthokeratology
- Patients with corneal endothelial cell density less than 2000 cells /mm2
- Patients who had worn rigid contact lenses (including orthokeratology lenses) within the previous 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness and Safety of Different Design of Orthokeratology Lenses to Reduce Myopia Growth
In this study, we intend to enroll orthokeratology subjects aged 8-18 years old with binocular myopia up to and including -4.00 D. They were randomly selected to wear both orthokeratology of different designs, one with an aspheric wide inversion zone design in the optical zone and the other with a traditional spherical curved segment design, and to investigate the differences between these two lenses in terms of their effectiveness in myopia retardation, defocus, and aberration.
- Conditions
- Myopia
- Being tested
- Orthokeratology with aspheric wide inversion zone design in the optical zone, Orthokeratology with traditional spherical design in the optical zone
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthokeratology with aspheric wide inversion zone design in the optical zoneDevice
An orthokeratology lens with an altered optical zone design is designed for an aspherical wide inversion arc in the optical zone
Orthokeratology with traditional spherical design in the optical zoneDevice
Subjects wore the orthokeratology with traditional spherical design in the optical zone
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Device: Orthokeratology with aspheric wide inversion zone design in the optical zone |
| Control group | Active comparator | Not described Receives: Device: Orthokeratology with traditional spherical design in the optical zone |
| Blank control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in axial length
Axial length was measured with a biometer
Measured: The change of baseline and 1years
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 Dec 2020
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956704
- Sponsor's protocol ID
- KY2023031
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Different Design of Orthokeratology Lenses to Reduce Myopia Growth
- ClinicalTrials.gov ID
- NCT05956704
- Acronym / sponsor ID
- KY2023031
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- 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.
In this study, we intend to enroll orthokeratology subjects aged 8-18 years old with binocular myopia up to and including -4.00 D. They were randomly selected to wear both orthokeratology of different designs, one with an aspheric wide inversion zone design in the optical zone and the other with a traditional spherical curved segment design, and to investigate the differences between these two lenses in terms of their effectiveness in myopia retardation, defocus, and aberration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Orthokeratology with aspheric wide inversion zone design in the optical zone |
| Control group | Active comparator | Device: Orthokeratology with traditional spherical design in the optical zone |
| Blank control group | No intervention | – |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- The age is greater than 8 years and less than 18 years
- The myopia was within -4.00D (including -4.00D), and the astigmatism was within 1.50D (including 1.50D) in both eyes.
- Be able to complete 12 months of follow-up
- They were able to understand the purpose of the trial, volunteered to participate, and signed informed consent by the subjects themselves or their legal guardians
Key exclusion criteria (14 listed)
- One eye met the inclusion criteria
- Patients with systemic diseases causing immunocompromised or affecting orthokeratology
- There are other eye diseases that affect orthokeratology lens wearing, such as dacryocystitis, blepharitis, various inflammation, glaucoma, etc
- Abnormal cornea
- Previous corneal surgery or corneal trauma history
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 |
|---|---|---|
| Orthokeratology with aspheric wide inversion zone design in the optical zoneAn orthokeratology lens with an altered optical zone design is designed for an aspherical wide inversion arc in the optical zone | Device | Experimental Group |
| Orthokeratology with traditional spherical design in the optical zoneSubjects wore the orthokeratology with traditional spherical design in the optical zone | Device | Control group |
Primary outcome
Changes in axial length
Time frame: The change of baseline and 1years
Axial length was measured with a biometer
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 21 Jul 2023.
- Individual participant dataSharing planned: No
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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.
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?
A study testing Orthokeratology with aspheric wide inversion zone design in the optical zone and Orthokeratology with traditional spherical design in the optical zone in people with 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 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 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?
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 (time frame: The change of baseline and 1years). 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.