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The aim of the proposed study is to investigate the predictive value of corneal biomechanical properties in corneal reshaping therapy and the role of these parameters in determining the amount of myopia reduction.
Experiment 1: To evaluate changes in corneal biomechanics caused by short-term corneal reshaping therapy.
Subjects will wear a conventional RGP lens in one eye, randomly selected, and an orthokeratology lens in the fellow eye, for 30 minutes, 60 minutes and one night, respectively. Corneal stiffness and tangent modulus will be measured before and after each wearing period.
Experiment 2: To evaluate changes in and the recovery of corneal biomechanics effected by long-term corneal reshaping and to assess whether corneal biomechanics can predict the rate of corneal reshaping.
Subjects will wear orthokeratology lenses for 6 months. Regular follow up visits (1 week, 1 month, 3 months and 6 months) will be arranged to monitor the changes in corneal stiffness and tangent modulus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corneal reshaping therapy | Experimental | Subjects will be wearing corneal reshaping lenses for the correction of their myopia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corneal reshaping therapy | Other | Reshaping the corneal curvature from wearing specific designed rigid gas permeable lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Corneal Stiffness From Baseline at 6 Months | Corneal Stiffness: in N/mm Corneal parameters usually will stabilize in 1 month, this study will monitor it till 6 months. | At baseline, then change from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Tangent Modulus From Baseline at 6 Months | Tangent modulus: in MPa Corneal parameters usually will stabilize in 1 month, this study will monitor it till 6 months. | At baseline, then change from baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew KC Lam, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Kowloon | HKG | Hong Kong |
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| ID | Title | Description |
|---|---|---|
| FG000 | Corneal Reshaping Therapy | Subjects will be wearing corneal reshaping lenses for the correction of their myopia Corneal reshaping therapy: Reshaping the corneal curvature from wearing specific designed rigid gas permeable lenses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Corneal Reshaping Therapy | Participants receiving Corneal Reshaping Therapy were monitored for ocular biometry and refractive errors throughout a 6-month period. Corneal stiffness and tangent modulus were outcome measures. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change of Corneal Stiffness From Baseline at 6 Months | Corneal Stiffness: in N/mm Corneal parameters usually will stabilize in 1 month, this study will monitor it till 6 months. | Posted | Mean | Standard Deviation | N/mm | At baseline, then change from baseline to 6 months |
|
|
6 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 | Treatment | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Lam | The Hong Kong Polytechnic University | 85227666109 | andrew.kc.lam@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 25, 2016 | Mar 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Participants |
| No |
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| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Change of Tangent Modulus From Baseline at 6 Months | Tangent modulus: in MPa Corneal parameters usually will stabilize in 1 month, this study will monitor it till 6 months. | Posted | Mean | Standard Deviation | MPa | At baseline, then change from baseline to 6 months |
|
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| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
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