Lacrifill for Ocular Surface Optimization in Cataract Surgery

June 12, 2026 updated by: The Eye Institute of West Florida

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects aged 40 years or older with diagnosed dry eye disease, totaling 65 eyes enrolled.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lacrifill Canalicular Filler
Observational Study
Device: Lacrifill Canalicular Filler
Lacrifill Canalicular Filler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean absolute error (MAE)
Time Frame: 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.
1 month postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in mean magnitude of postoperative refractive astigmatism
Time Frame: 1 month postoperatively
1 month postoperatively
Lens type candidacy
Time Frame: Preoperative assessment
Evaluation of patient eligibility for IOL based on improved ocular surface conditions and investigator medical judgement.
Preoperative assessment
Postoperative uncorrected visual acuity (logMAR)
Time Frame: 1 month postoperatively
1 month postoperatively
Subjective visual satisfaction
Time Frame: 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.
1 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Eye Institute of West Florida

Collaborators

Sengi

Investigators

  • Principal Investigator: Neel Desai, MD, The Eye Institute of West Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2026

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

July 15, 2027

Study Registration Dates

First Submitted

June 9, 2026

First Submitted That Met QC Criteria

June 12, 2026

First Posted (Actual)

June 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ND-26-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract

Clinical Trials on Lacrifill Canalicular Filler

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe