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lack of efficacy
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| Name | Class |
|---|---|
| Glaukos Corporation | INDUSTRY |
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43 Subjects (43 eyes) qualified for participation will undergo the required screening procedures to determine study eligibility. The surgical protocol involves applying riboflavin 0,22% to 0,25 % up to 20 minutes . Then, the eyes will be exposed to UVA (ultraviolet A) light with the KXL II system according to the programmed treatment pattern.
All use of the KXL II system will be in accordance with the general instructions in the operator's manual. All subjects will be evaluated at screening, Day 3, and 1, 3, 6 ,12 and 24 months after treatment.
Manual keratometry, manifest refraction, uncorrected visual acuity, best corrected visual acuity, slit lamp biomicroscopy, pentacam measurements and placido disc topography (TMS), will be obtained at baseline and at appropriate times after the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corneal cross linking (CXL) | Experimental | Applying riboflavin 0,22% to 0,25 % up to 20 minutes . Then, the eyes are exposed to Ultraviolet A light with the KXL II system according to the programmed treatment pattern. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CXL Myopia | Device | Applying riboflavin 0,22% to 0,25 % up to 20 minutes . Then, the eyes are exposed to UVA light with the KXL II system according to the programmed treatment pattern. |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity | 1 month | |
| Best corrected visual acuity | 3 months | |
| Best corrected visual acuity | 6 months | |
| Best corrected visual acuity | 12 months | |
| Best corrected visual acuity | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Clinical examination and slit lamp biomicroscopy | 1 month |
| Adverse events | Clinical examination and slit lamp biomicroscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François MALECAZE, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toulouse University Hospital | Toulouse | France |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| 3 months |
| Adverse events | Clinical examination and slit lamp biomicroscopy | 6 months |
| Adverse events | Clinical examination and slit lamp biomicroscopy | 12 months |
| Adverse events | Clinical examination and slit lamp biomicroscopy | 24 months |
| Uncorrected visual acuity | 3 months |
| Mean change in manifest refraction spherical equivalent from baseline | 3 months |
| Mean change in corneal curvature from baseline | 3 months |