Health TrialsbyHealthPanel

Lacrifill for Ocular Surface Optimization in Cataract Surgery

ConditionCataract
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorThe Eye Institute of West Florida

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Previous punctal plugs or canalicular cautery

Active ocular inflammation or corneal pathology unrelated to DED

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Lacrifill Canalicular Filler

    Device

    Lacrifill Canalicular Filler

Treatment groups

65 Participants
are divided into 1 treatment group
Group A: Lacrifill Canalicular Filler1 intervention

Trial outcomes

Primary outcomes

1

Mean absolute error (MAE)

Difference in mean spherical equivalent Mean Absolute Error (MAE) between actual postoperative manifest refraction spherical equivalent and back-calculated equivalent based on baseline biometry.

Time frame
1 month postoperatively

Secondary outcomes

1

Difference in mean magnitude of postoperative refractive astigmatism

Time frame
1 month postoperatively
2

Lens type candidacy

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

Time frame
Preoperative assessment
3

Postoperative uncorrected visual acuity (logMAR)

Time frame
1 month postoperatively
4

Subjective visual satisfaction

National Eye Institute Visual Functioning Questionnaire 25 (VFQ-25). Graded on a scale from 1 to 5 with lower scores indicative of higher satisfaction.

Time frame
1 month postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Eye Institute of West Florida

Lead sponsor

Sengi

Collaborator

Source ClinicalTrials.gov
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