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| Name | Class |
|---|---|
| LensAR Incorporated | INDUSTRY |
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This study aims to evaluate the safety and effectiveness of femtosecond laser arcuate corneal relaxing incisions (AK) combined with Light Adjustable Lens (LAL) implantation for correcting pre-existing corneal astigmatism in patients undergoing cataract or refractive lens exchange surgery. Postoperative assessments will focus on residual refractive astigmatism, visual outcomes, patient satisfaction, and the incidence of adverse events. Arcuate keratotomy and toric IOLs are well-established methods for astigmatism correction, and this study will compare their combined effectiveness using advanced femtosecond laser technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femto arcs + LAL | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femto arcs | Other | Femtosecond laser-assisted arcuate corneal relaxing incisions (AK) will be performed to correct astigmatism. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of LAL adjustments required to achieve the desired refraction | 8 weeks after last lock-in |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of eyes with residual refractive astigmatism ≤ 0.50 D | 8 weeks after last lock-in |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helga P Sandoval | Contact | 8438813937 | hps@cepmd.com |
| Name | Affiliation | Role |
|---|---|---|
| Priya Mathews, MD | Center For Sight - Clinical Studies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center For Sight | Recruiting | Venice | Florida | 34285 | United States |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Light Adjustable Lens (LAL) | Device | The LAL is intended to replace the natural lens at time of lens removal. |
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| Carolina Eyecare Physicians | Recruiting | Mt. Pleasant | South Carolina | 29464 | United States |
|