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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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This is a single-site observational study designed to evaluate the efficacy of Lacrifill™ canalicular filler in optimizing ocular surface parameters and biometric precision in prospective cataract surgery patients with dry eye disease (DED).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacrifill Canalicular Filler | Observational Study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacrifill Canalicular Filler | Device | Lacrifill Canalicular Filler |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean absolute error (MAE) | Difference in mean spherical equivalent Mean Absolute Error (MAE) between actual postoperative manifest refraction spherical equivalent and back-calculated equivalent based on baseline biometry. | 1 month postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mean magnitude of postoperative refractive astigmatism | 1 month postoperatively | |
| Lens type candidacy | Evaluation of patient eligibility for IOL based on improved ocular surface conditions and investigator medical judgement. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects aged 40 years or older with diagnosed dry eye disease, totaling 65 eyes enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renee Bondurant | Contact | 727-450-4668 | Renee.Bondurant@eyespecialist.com |
| Name | Affiliation | Role |
|---|---|---|
| Neel Desai, MD | The Eye Institute of West Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eye Institute of West Florida | Largo | Florida | 33770 | United States |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Preoperative assessment |
| Postoperative uncorrected visual acuity (logMAR) | 1 month postoperatively |
| Subjective visual satisfaction | National Eye Institute Visual Functioning Questionnaire 25 (VFQ-25). Graded on a scale from 1 to 5 with lower scores indicative of higher satisfaction. | 1 month postoperatively |