MyopiaNCT03616600
The Safety and Effectiveness of Breath-O Lenses
A study testing Breath-O-Correct Lens in people with Myopia and Safety Issues, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
In Hong Kong, approximately 80% of children are myopic by the end of childhood. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression. One of the most successful treatments for myopia is orthokeratology. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Safety Issues
- What is being tested?
- Breath-O-Correct Lens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2018to 15 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Refractive error: Spherical: normally -1.00D to -4.00D (maximum up to -5.00D); Cylindrical: normally half of Sph (against-the-rule Astigmatism.: lower than -0.75D) (maximum up to -1.50D)
- Best corrected Visual acuity: monocular ETDRS 0.0 or better
- Ocular health: No ocular abnormality, no contra-indications for overnight orthokeratology lens wear, no refractive surgery
- General health: No systemic diseases
- Requirement: No history of orthokeratology lens wearing. Agree to participate in this study and willing to wear the orthokeratology lenses overnight in accordance with the instructions given and to come back for follow up within the study period
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Effectiveness of Clinical Performance of Breath-O Correct Orthokeratology Lenses
In Hong Kong, approximately 80% of children are myopic by the end of childhood. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression. One of the most successful treatments for myopia is orthokeratology. Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.
Read the detailed description
Short-sightedness (myopia) is the most common refractive error in the world. In Hong Kong, approximately 80% of children are myopic by the end of childhood. Current treatment strategies to control (i.e. slow) myopia progression in children are primarily designed to harness the natural "emmetropization" process, in which visual feedback from retinal image clarity regulates the rate of eye growth. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression, not least since this approach permits clear central vision. One of the most successful treatments for myopia is orthokeratology, which is a therapy of using custom-made rigid gas permeable contact lens. The special design of this contact lens can reshape the corneal profile to minimize the central refractive error while producing beneficial peripheral defocus. Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.
- Conditions
- Myopia, Safety Issues
- Being tested
- Breath-O-Correct Lens
- Keywords
- Myopia, Orthokeratology
- 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-Correct LensOther
Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Wearing the orthokeratology lenses for 3 months Receives: Other: Breath-O-Correct Lens |
| Control | No intervention | Not wearing any contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor
measured by ocular response analyser
Measured: Baseline, 1st Month, 3rd Month
Corneal Endothelial Health in Terms of Endothelial Cell Density
measured by specular microscope
Measured: Baseline, 1st Month, 3rd Month
Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size
measured by specular microscope
Measured: Baseline, 1st Month, 3rd Month
Anterior Ocular Health in Terms of Limbal and Bulbar Redness
measured by OCULUS Keratograph® 5M and graded by JENVIS redness grading system It is a scale of 0 to 4, the higher the score, the more redness the ocular surface manifests
Measured: Baseline, 1st Month, 3rd Month
Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)
measured by OCULUS Keratograph® 5M
Measured: Baseline, 1st Month, 3rd Month
Secondary outcomes (2)
Best Corrected Visual Acuity in Terms of High and Low Contrast
The best corrected visual acuity was measured in LogMAR (Snellen 20/20 vision = 0.00 in LogMAR ; each readable letter add -0.02 to the score, the smaller the number i.e. more negative, the better visual acuity)
Measured: Baseline, 1st Month and the 3rd Month
Reduction of the Refractive Power After Wearing the Breath-O-correct Lens
Refractive errors were determined by subjective refraction for treatment group (Breath-O correct lens wearer), the outcome was represented as mean spherical equivalent refraction with unit in diopter (SER, = 1/2 Cylindrical power + spherical power)
Measured: Baseline, 1st Week, 1st Month, 3rd Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Mar 2018
- Primary completion31 Aug 2018
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 control trial
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- SEED Co. Ltd.
- Responsible party
- Principal investigator, Henry HL Chan, PhD, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616600
- Sponsor's protocol ID
- HongKongPU_Optometry2
- Status last verified
- Jan 2021
- First submitted
- 15 Mar 2018
- Last updated
- 10 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of Clinical Performance of Breath-O Correct Orthokeratology Lenses
- ClinicalTrials.gov ID
- NCT03616600
- Acronym / sponsor ID
- HongKongPU_Optometry2
- Conditions
- Myopia, Safety Issues
- Keywords
- Myopia, Orthokeratology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- SEED Co. Ltd.
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Posted 13 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Hong Kong, approximately 80% of children are myopic by the end of childhood. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression. One of the most successful treatments for myopia is orthokeratology. Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.
Detailed description
Short-sightedness (myopia) is the most common refractive error in the world. In Hong Kong, approximately 80% of children are myopic by the end of childhood. Current treatment strategies to control (i.e. slow) myopia progression in children are primarily designed to harness the natural "emmetropization" process, in which visual feedback from retinal image clarity regulates the rate of eye growth. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression, not least since this approach permits clear central vision. One of the most successful treatments for myopia is orthokeratology, which is a therapy of using custom-made rigid gas permeable contact lens. The special design of this contact lens can reshape the corneal profile to minimize the central refractive error while producing beneficial peripheral defocus. Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Breath-O-Correct LensWearing the orthokeratology lenses for 3 months |
| Control | No intervention | –Not wearing any contact lenses |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Refractive error: Spherical: normally -1.00D to -4.00D (maximum up to -5.00D); Cylindrical: normally half of Sph (against-the-rule Astigmatism.: lower than -0.75D) (maximum up to -1.50D)
- Best corrected Visual acuity: monocular ETDRS 0.0 or better
- Ocular health: No ocular abnormality, no contra-indications for overnight orthokeratology lens wear, no refractive surgery
- General health: No systemic diseases
- Requirement: No history of orthokeratology lens wearing. Agree to participate in this study and willing to wear the orthokeratology lenses overnight in accordance with the instructions given and to come back for follow up within the study period
Key exclusion criteria (0 listed)
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-Correct LensBreath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material | Other | Treatment |
Primary outcome
Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor
Time frame: Baseline, 1st Month, 3rd Month
measured by ocular response analyser
Corneal Endothelial Health in Terms of Endothelial Cell Density
Time frame: Baseline, 1st Month, 3rd Month
measured by specular microscope
Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size
Time frame: Baseline, 1st Month, 3rd Month
measured by specular microscope
Anterior Ocular Health in Terms of Limbal and Bulbar Redness
Time frame: Baseline, 1st Month, 3rd Month
measured by OCULUS Keratograph® 5M and graded by JENVIS redness grading system It is a scale of 0 to 4, the higher the score, the more redness the ocular surface manifests
Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)
Time frame: Baseline, 1st Month, 3rd Month
measured by OCULUS Keratograph® 5M
2 secondary outcomes
Best Corrected Visual Acuity in Terms of High and Low Contrast
Time frame: Baseline, 1st Month and the 3rd Month
Reduction of the Refractive Power After Wearing the Breath-O-correct Lens
Time frame: Baseline, 1st Week, 1st Month, 3rd Month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Breath-O-Correct Lens in people with Myopia and Safety Issues, 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 5 inclusion and 0 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 10 Feb 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 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?
Yes. Results are posted in the registry (first posted 13 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor (time frame: Baseline, 1st Month, 3rd Month). 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?
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 10 Feb 2021.