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Not yet recruiting NCT07648095

Lacrifill for Ocular Surface Optimization in Cataract Surgery

— Observational Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lacrifill Canalicular Filler.
Who it may be relevant to
Registry conditions: Cataract. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Device Lacrifill Canalicular Filler
    Lacrifill Canalicular Filler

Primary outcome measures

  • Mean absolute error (MAE) [Time frame: 1 month postoperatively]
Secondary outcome measures (4)
  • Difference in mean magnitude of postoperative refractive astigmatism [Time frame: 1 month postoperatively]
  • Lens type candidacy [Time frame: Preoperative assessment]
  • Postoperative uncorrected visual acuity (logMAR) [Time frame: 1 month postoperatively]
  • Subjective visual satisfaction [Time frame: 1 month postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • The Eye Institute of West Florida — Largo

Identifiers

NCT: NCT07648095 · ND-26-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗