Cataract
Conditions
Brief summary
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).
Interventions
Lacrifill Canalicular Filler
Sponsors
Study design
Eligibility
Inclusion criteria
* Age \>= 40 years * Diagnosed dry eye (OSDI \>= 13, TBUT \< 10 sec, or Oxford staining \>= Grade 2) * No recent ocular surgeries (\<6 months) * No significant changes in DED regimen within last 1 month
Exclusion criteria
* Previous punctal plugs or canalicular cautery * Active ocular inflammation or corneal pathology unrelated to DED
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean absolute error (MAE) | 1 month postoperatively | Difference in mean spherical equivalent Mean Absolute Error (MAE) between actual postoperative manifest refraction spherical equivalent and back-calculated equivalent based on baseline biometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in mean magnitude of postoperative refractive astigmatism | 1 month postoperatively | — |
| Lens type candidacy | Preoperative assessment | Evaluation of patient eligibility for IOL based on improved ocular surface conditions and investigator medical judgement. |
| Postoperative uncorrected visual acuity (logMAR) | 1 month postoperatively | — |
| Subjective visual satisfaction | 1 month postoperatively | National Eye Institute Visual Functioning Questionnaire 25 (VFQ-25). Graded on a scale from 1 to 5 with lower scores indicative of higher satisfaction. |
Countries
United States
Contacts
The Eye Institute of West Florida