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Lacrifill for Ocular Surface Optimization in Cataract Surgery

Evaluation of Lacrifill™ Canalicular Filler for Optimization of Ocular Surface Parameters and Biometric Precision in Prospective Cataract Surgery Patients With Dry Eye Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07648095
Enrollment
65
Registered
2026-06-15
Start date
2026-07-22
Completion date
2027-07-15
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

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

DEVICELacrifill Canalicular Filler

Lacrifill Canalicular Filler

Sponsors

The Eye Institute of West Florida
Lead SponsorOTHER
Sengi
CollaboratorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Mean absolute error (MAE)1 month postoperativelyDifference in mean spherical equivalent Mean Absolute Error (MAE) between actual postoperative manifest refraction spherical equivalent and back-calculated equivalent based on baseline biometry.

Secondary

MeasureTime frameDescription
Difference in mean magnitude of postoperative refractive astigmatism1 month postoperatively
Lens type candidacyPreoperative assessmentEvaluation 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 satisfaction1 month postoperativelyNational 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

CONTACTRenee Bondurant
Renee.Bondurant@eyespecialist.com727-450-4668
PRINCIPAL_INVESTIGATORNeel Desai, MD

The Eye Institute of West Florida

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026