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| Name | Class |
|---|---|
| SEED Co. Ltd. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Wearing the orthokeratology lenses for 3 months |
|
| Control | No Intervention | Not wearing any contact lenses |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath-O-Correct Lens | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor | measured by ocular response analyser | Baseline, 1st Month, 3rd Month |
| Corneal Endothelial Health in Terms of Endothelial Cell Density | measured by specular microscope | Baseline, 1st Month, 3rd Month |
| Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size | measured by specular microscope | 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 | Baseline, 1st Month, 3rd Month |
| Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT) | measured by OCULUS Keratograph® 5M | Baseline, 1st Month, 3rd Month |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, 1st Month and the 3rd Month |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Hong Kong | Hong Kong |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Wearing the orthokeratology lenses for 3 months Breath-O-Correct Lens: 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 |
| FG001 | Control | Not wearing any contact lenses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Wearing the orthokeratology lenses for 3 months Breath-O-Correct Lens: 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 |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor | measured by ocular response analyser | Posted | Mean | Standard Deviation | mmHg | Baseline, 1st Month, 3rd Month |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Wearing the orthokeratology lenses for 3 months Breath-O-Correct Lens: 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| poor visual quality | Eye disorders | Non-systematic Assessment | symptoms like glare and reduction in contrast from orthokeratology wearing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Henry Chan | Hong Kong Polytechnic University | +85227667937 | henryhl.chan@polyu.edu.hk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2019 | Jun 26, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Randomized control trial
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| 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) |
| Baseline, 1st Week, 1st Month, 3rd Month |
Not wearing any contact lenses |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Refractive errors | Mean | Standard Deviation | Diopters |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Corneal Endothelial Health in Terms of Endothelial Cell Density | measured by specular microscope | Posted | Mean | Standard Deviation | cell/mm^2 | Baseline, 1st Month, 3rd Month |
|
|
|
| Secondary | 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) | It is a comparison of visual performance before-and-after treatment and therefore only the best corrected visual acuity in treatment group in different time points were compared. | Posted | Mean | Standard Deviation | LogMAR | Baseline, 1st Month and the 3rd Month |
|
|
|
| Secondary | 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) | It is a comparison of refractive errors before-and-after treatment and therefore only the refractive errors in treatment group in different time points were compared. | Posted | Mean | Standard Deviation | Diopter | Baseline, 1st Week, 1st Month, 3rd Month |
|
|
|
| Primary | Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size | measured by specular microscope | Posted | Mean | Standard Deviation | percentage | Baseline, 1st Month, 3rd Month |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1st Month, 3rd Month |
|
|
|
| Primary | Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT) | measured by OCULUS Keratograph® 5M | Posted | Mean | Standard Deviation | Second | Baseline, 1st Month, 3rd Month |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | Control | Not wearing any contact lenses | 0 | 15 | 0 | 15 | 0 | 15 |
|
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| Corneal Endothelial Cell Density_3rd month |
|
| Title | Measurements |
|---|---|
|
| Low contrast VA_Basline |
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| Low contrast VA_1st Month |
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| Low contrast VA_3rd Month |
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| Title | Measurements |
|---|---|
|
| Refractive errors_3rd Month |
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| Corneal Endothelial Cell Variance_3rd month |
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| Bulbar redness_3rd Month |
|
| Limbal redness_Baseline |
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| Limbal redness_1st Month |
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| Limbal redness_3rd Month |
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| NIKBUT_1st break_3rd Month |
|
| NIKBUT_average_Baseline |
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| NIKBUT_average_1st Month |
|
| NIKBUT_average_3rd Month |
|