MyopiaNCT03919396
Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses
A study testing Breath-O orthokeratology lenses in people with Myopia and Orthokeratology, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This is a 24-month longitudinal randomized controlled trial aiming to evaluate the effectiveness of myopia control by Breath-O correct orthokeratology lenses in different myopia progression groups classified according to their initial electro-retinal responses. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Orthokeratology
- What is being tested?
- Breath-O orthokeratology lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2019to 31 Dec 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Refractive error: Spherical: -1.00D to -4.00D; Cylindrical: half of Sph (against-the-rule Astig.: less than -0.75D)
- Best corrected Visual acuity: monocular ETDRS 0.1 or better
Who cannot join
- Ocular abnormality
- Contra-indicated for overnight orthokeratology lens wear
- History of refractive surgery
- Systemic diseases
- History of orthokeratology lenses wearing or other myopia control methods
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Optometry, Hong Kong Polytechnic University
Hong Kong, 00000
About this study
Official title: Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses in Different Myopia Progression Groups
This is a 24-month longitudinal randomized controlled trial aiming to evaluate the effectiveness of myopia control by Breath-O correct orthokeratology lenses in different myopia progression groups classified according to their initial electro-retinal responses.
Read the detailed description
Myopia is the most common refractive error in the world. In Hong Kong, the number of children in myopia is on the rise and approximately 80% of children are myopic by the end of childhood. Orthokeratology is one of the most successful myopia control methods adopting the strategy of peripheral defocus, in which the natural emmetropization process is harnessed by the myopic defocus induced by the orthokeratology lenses.Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with higher elasticity as compared traditional lens material.
A recent study has shown young children with an initial weakened central electrical signal from the inner retina had faster myopia progression as measured by multifocal electroretinogram(ERG). We will classify the slow and fast progression group based on the ERG results, so as to evaluate the clinical effectiveness of the newly designed lenses in controlling myopia in children with different rates of progression.
- Conditions
- Myopia, Orthokeratology
- Being tested
- Breath-O orthokeratology lenses
- Keywords
- Myopia, Myopia Control, Orthokeratology, Electroretinogram, Multifocal Electroretinogram
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath-O orthokeratology lensesDevice
Specially designed rigid gas permeable lenses which
- reshapes corneal profile for myopia control
- has higher elasticity compared to traditional lens material.
| Study group | Role | What they receive |
|---|---|---|
| OrthoK (orthokeratology) | Experimental | Group wearing Breath-O corrected orthokeratology lenses for 2 years Receives: Device: Breath-O orthokeratology lenses |
| SV Lenses (Single vision) | No intervention | Group wearing spectacle with single vision lenses for 2 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Refraction
Refractive Error ( in Diopter )
Measured: up to 24 months
Secondary outcomes (1)
Axial Length
Length of eye ball
Measured: 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 posted18 Apr 2019
- Study start1 Apr 2019
- Primary completion31 Oct 2019
- Study completion31 Dec 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.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Model description
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- SEED Co. Ltd.
- Responsible party
- Sponsor
- Investigators
- Henry HL Chan, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919396
- Sponsor's protocol ID
- HongKongPU_Optometry3
- Status last verified
- Aug 2021
- First submitted
- 16 Apr 2019
- Last updated
- 1 Mar 2023
- 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 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses in Different Myopia Progression Groups
- ClinicalTrials.gov ID
- NCT03919396
- Acronym / sponsor ID
- HongKongPU_Optometry3
- Conditions
- Myopia, Orthokeratology
- Keywords
- Myopia, Myopia Control, Orthokeratology, Electroretinogram, Multifocal Electroretinogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- SEED Co. Ltd.
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 Apr 2019 (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.
This is a 24-month longitudinal randomized controlled trial aiming to evaluate the effectiveness of myopia control by Breath-O correct orthokeratology lenses in different myopia progression groups classified according to their initial electro-retinal responses.
Detailed description
Myopia is the most common refractive error in the world. In Hong Kong, the number of children in myopia is on the rise and approximately 80% of children are myopic by the end of childhood. Orthokeratology is one of the most successful myopia control methods adopting the strategy of peripheral defocus, in which the natural emmetropization process is harnessed by the myopic defocus induced by the orthokeratology lenses.Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with higher elasticity as compared traditional lens material.
A recent study has shown young children with an initial weakened central electrical signal from the inner retina had faster myopia progression as measured by multifocal electroretinogram(ERG). We will classify the slow and fast progression group based on the ERG results, so as to evaluate the clinical effectiveness of the newly designed lenses in controlling myopia in children with different rates of progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| OrthoK (orthokeratology) | Experimental | Device: Breath-O orthokeratology lensesGroup wearing Breath-O corrected orthokeratology lenses for 2 years |
| SV Lenses (Single vision) | No intervention | –Group wearing spectacle with single vision lenses for 2 years |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Refractive error: Spherical: -1.00D to -4.00D; Cylindrical: half of Sph (against-the-rule Astig.: less than -0.75D)
- Best corrected Visual acuity: monocular ETDRS 0.1 or better
Key exclusion criteria (5 listed)
- Ocular abnormality
- Contra-indicated for overnight orthokeratology lens wear
- History of refractive surgery
- Systemic diseases
- History of orthokeratology lenses wearing or other myopia control methods
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 |
|---|---|---|
| Breath-O orthokeratology lensesSpecially designed rigid gas permeable lenses which 1. reshapes corneal profile for myopia control 2. has higher elasticity compared to traditional lens material. | Device | OrthoK (orthokeratology) |
Primary outcome
Subjective Refraction
Time frame: up to 24 months
Refractive Error ( in Diopter )
1 secondary outcome
Axial Length
Time frame: up to 24 months
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 1 Mar 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.
Henry HL Chan, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath-O orthokeratology lenses in people with Myopia and Orthokeratology, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 2 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 1 Mar 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 Hong Kong. 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?
Subjective Refraction (time frame: up to 24 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 1 Mar 2023.