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| Name | Class |
|---|---|
| Robert Ang, MD | UNKNOWN |
| Robert Ang, MD - Asian Eye Institute | 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 | Open label treatment arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative refractive crosslinking | Device | Non-invasive corneal cross-linking device delivering controlled UV light through a contact lens platform for biomechanical stabilization 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 |
|---|---|---|---|---|---|---|
| Asian Eye Institute | Makati City | Philippines | Philippines |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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