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RecruitingNCT07648095Updated Aug 21, 2026

Lacrifill for Ocular Surface Optimization in Cataract Surgery

An observational study in Cataract, sponsored by The Eye Institute of West Florida. Recruiting at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by The Eye Institute of West Florida · Observational

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
65
Ages
40 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Cataract

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03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 65 is below the median of 89 across 475 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

The Eye Institute of West Florida is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Previous punctal plugs or canalicular cautery
  • Active ocular inflammation or corneal pathology unrelated to DED
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
65 participants (estimated)

Groups and cohorts

  • Lacrifill Canalicular Filler

    Observational Study

    Device: Lacrifill Canalicular Filler

Interventions

  • DeviceLacrifill Canalicular Filler

    Lacrifill Canalicular Filler

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What researchers measure

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

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07648095
Lead sponsor
The Eye Institute of West Florida
Collaborators
Sengi
Responsible party
Sponsor
First posted
Jun 15, 2026
Start date
Jul 22, 2026
Primary completion
Jul 15, 2027 (estimated)
Completion
Jul 15, 2027 (estimated)
Last update
Aug 21, 2026

Study contacts

Renee Bondurant
Contact
Renee.Bondurant@eyespecialist.com
727-450-4668
Neel Desai, MD
principal investigator · The Eye Institute of West Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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