MyopiaNCT06825585
Efficacy and Visual Quality of Orthokeratology Lenses With Different Designs
A study testing Orthokeratology with 5.0mm back optical zone diameter and Orthokeratology with a 6.2 mm back optical zone diameter in people with Myopia and Myopia; Refractive Error, run by Xiaoyan Yang at 1 site in China.
Trial summary
Orthokeratology (ortho-k) lens is very effective in slowing down axial elongation in myopic children by 30% to 63% when compared to children wearing single-vision spectacles or contact lenses. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Myopia; Refractive Error
- What is being tested?
- Orthokeratology with 5.0mm back optical zone diameter and Orthokeratology with a 6.2 mm back optical zone diameter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 May 2022
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 8 and 13 years.
- Subjective refraction under cycloplegia: spherical power between -4.00 D and
- 1.00 D, with cylindrical power≤ 1.50 D.
- Best-corrected visual acuity (BCVA) of ≥ 1.0 based on subjective refraction.
- Willing to participate in the clinical trial and provide signed informed consent.
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)
Show all 14Show fewer
- 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.
China1 site
Tianjin Eye Hospital Opotometric Center
Tianjin, Tianjin Municipality, 300020
About this study
Orthokeratology (ortho-k) lens is very effective in slowing down axial elongation in myopic children by 30% to 63% when compared to children wearing single-vision spectacles or contact lenses. More recently, it is reported that the children wearing orthok lens of smaller back optical zone diameter (BOZD) demonstrated a smaller axial elongation when compared to children wearing lens with larger BOZD. We aimed to explored the myopia efficacy and visual quality of ortho-k with different BOZD (5.0mm or 6.2mm).
Read the detailed description
This prospective study aimed to evaluate the efficacy of orthokeratology lenses with different back optical zone diameters (BOZD) in slowing axial elongation. Additionally, visual quality will be assessed through measurements of wavefront aberrations, contrast sensitivity, and subjective visual quality using a validated questionnaire. The study seeks to explore the effectiveness of various Ortho-K lens designs and the potential factors influencing their outcomes.
- Conditions
- Myopia, Myopia; Refractive Error
- Being tested
- Orthokeratology with 5.0mm back optical zone diameter, Orthokeratology with a 6.2 mm back optical zone diameter
- 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.
Orthokeratology with 5.0mm back optical zone diameterDevice
The orthokeratology lenses used in this study were Double Reservoir Lenses (DRL) manufactured by Precilens (Creteil, France). The lenses feature a dual reverse-curve design with a back optic zone diameter (BOZD) of 5.0 mm.
Orthokeratology with a 6.2 mm back optical zone diameterDevice
The orthokeratology lenses used were Euclid lenses manufactured by Euclid Systems (Herndon, VA, USA). These lenses feature a four-zone, five-curve design with a back optic zone diameter (BOZD) of 6.2 mm.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Myopic children who need OK lens treatment Receives: Device: Orthokeratology with 5.0mm back optical zone diameter |
| Control group | Active comparator | Myopic children who need OK lens treatment Receives: Device: Orthokeratology with a 6.2 mm back optical zone diameter |
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 posted13 Feb 2025
- Study start1 Jan 2021
- Primary completion31 Mar 2022
- Study completion31 May 2022
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaoyan Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaoyan Yang, Tianjin Eye Hospital
- Investigators
- Tianjin Eye Hospital, Principal investigator, Tianjin Eye Hospital Opotometic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825585
- Sponsor's protocol ID
- Different Orthk lens
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Visual Quality of Orthokeratology Lenses With Different Designs
- ClinicalTrials.gov ID
- NCT06825585
- Acronym / sponsor ID
- Different Orthk lens
- Conditions
- Myopia, Myopia; Refractive Error
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Xiaoyan YangUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 13 Feb 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 (ortho-k) lens is very effective in slowing down axial elongation in myopic children by 30% to 63% when compared to children wearing single-vision spectacles or contact lenses. More recently, it is reported that the children wearing orthok lens of smaller back optical zone diameter (BOZD) demonstrated a smaller axial elongation when compared to children wearing lens with larger BOZD. We aimed to explored the myopia efficacy and visual quality of ortho-k with different BOZD (5.0mm or 6.2mm).
Detailed description
This prospective study aimed to evaluate the efficacy of orthokeratology lenses with different back optical zone diameters (BOZD) in slowing axial elongation. Additionally, visual quality will be assessed through measurements of wavefront aberrations, contrast sensitivity, and subjective visual quality using a validated questionnaire. The study seeks to explore the effectiveness of various Ortho-K lens designs and the potential factors influencing their outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Orthokeratology with 5.0mm back optical zone diameterMyopic children who need OK lens treatment |
| Control group | Active comparator | Device: Orthokeratology with a 6.2 mm back optical zone diameterMyopic children who need OK lens treatment |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age between 8 and 13 years.
- Subjective refraction under cycloplegia: spherical power between -4.00 D and
- 1.00 D, with cylindrical power≤ 1.50 D.
- Best-corrected visual acuity (BCVA) of ≥ 1.0 based on subjective refraction.
- Willing to participate in the clinical trial and provide signed informed consent.
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 5.0mm back optical zone diameterThe orthokeratology lenses used in this study were Double Reservoir Lenses (DRL) manufactured by Precilens (Creteil, France). The lenses feature a dual reverse-curve design with a back optic zone diameter (BOZD) of 5.0 mm. | Device | Experimental Group |
| Orthokeratology with a 6.2 mm back optical zone diameterThe orthokeratology lenses used were Euclid lenses manufactured by Euclid Systems (Herndon, VA, USA). These lenses feature a four-zone, five-curve design with a back optic zone diameter (BOZD) of 6.2 mm. | 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 13 Feb 2025.
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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.
Tianjin Eye Hospital principal investigator
Tianjin Eye Hospital Opotometic Center
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 5.0mm back optical zone diameter and Orthokeratology with a 6.2 mm back optical zone diameter in people with Myopia and Myopia; Refractive Error, run by Xiaoyan Yang 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 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 13 Feb 2025. 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 13 Feb 2025.