Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07648095

Lacrifill for Ocular Surface Optimization in Cataract Surgery

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).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Eye Institute of West Florida

Largo, Florida, 33770, United States

Location contact

Neel R Desai, MD

PRINCIPAL_INVESTIGATOR

Renee Bondurant

CONTACT

[email protected]

727-450-4668

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacrifill Canalicular Filler

Device

Lacrifill Canalicular Filler

Primary outcomes

  1. 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.

Secondary outcomes

  1. Difference in mean magnitude of postoperative refractive astigmatism

    Time frame: 1 month postoperatively

  2. Lens type candidacy

    Time frame: Preoperative assessment

    Evaluation of patient eligibility for IOL based on improved ocular surface conditions and investigator medical judgement.

  3. Postoperative uncorrected visual acuity (logMAR)

    Time frame: 1 month postoperatively

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Renee Bondurant

CONTACT

[email protected]

727-450-4668

Sponsors and collaborators

Lead sponsor

The Eye Institute of West Florida

Other

Collaborators

  • Sengi

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.