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A prospective, multicenter, randomized, controlled clinical trial of orthokeratology lens
The test product is the orthokeratology lens, and the control product is a commercially available orthokeratology lens. The number of enrolled subjects is 390, and clinical observation is performed for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Randomized to Treatment |
|
| Control | Active Comparator | Randomized to Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test orthokeratology lens | Device | Randomized to test orthokeratology lens worn during sleep every night |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | uncorrected visual acuity measured using logMAR chart | 1 year |
| Axial length | axial eye length in millimeter measured by MYAH (Topcon) and IOL master (ZEISS) | 1 year |
| Refraction | spherical and cylinder power in diopter for best corrected visual acuity measured subjectively | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse events are classified into moderate, middle, or severe. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
<At screening>
(1) Those who are determined to be unable to obtain good centralized positioning even though changing strength (2) Pregnancy confirmed (3) Those who are difficult in continuing the clinical trial at investigator's discretion
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| Name | Affiliation | Role |
|---|---|---|
| Stan Isaacs | I & Vision Research Centre Pte. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I&VISION Research Centre | Singapore | 248649 | Singapore | |||
| Myopia Specialist Centre |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Control orthokeratology lens | Device | Randomized to control orthokeratology lens worn during sleep every night |
|
| Singapore |
| 248649 |
| Singapore |
| Stan Isaacs | Singapore | 248649 | Singapore |