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| Name | Class |
|---|---|
| Renato Ambrósio, MD - Rio Vision; Tijuca Rio de Janeiro, Brazil | UNKNOWN |
| Juan Batlle, Jr. MD - Laser Center; Santo Domingo, Dominican Rep. | UNKNOWN |
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An 'on-eye' UV delivery system for corneal crosslinking can be used safely and effectively to help free presbyopic patients from the need for reading glasses.
The clinical trial is evaluating the TECLens CXLens Crosslinking System, an investigational treatment using ultraviolet (UV) light (375 nm) with riboflavin (vitamin B2) to strengthen and reshape the cornea. By creating controlled biomechanical changes, this study aims to test whether the cornea can be reshaped to reduce refractive errors such as mild myopia or hyperopia in patients of presbyopic age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Epithelium-on Corneal Crosslinking |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative refractive crosslinking | Device | Non-invasive corneal crosslinking device delivering controlled UV light through a contact lens platform for refractive reshaping of the cornea. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduce refractive error | Achieve manifest refraction outcome at 3 months post treatment within 0.75D of the pre-planned targeted refraction, in patients aged 40 to 65 years old | 3-months post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Lopath | Contact | 919-824-5224 | plopath@teclens.com | |
| Ibrahim Seven | Contact | 440-485-9091 | ibrahim.seven@teclens.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rio Vision Hospital Oftalmológico | Rio de Janeiro | Brazil |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Laser Center | Santo Domingo | Dominican Republic |
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