CataractNCT07648095
Lacrifill for Ocular Surface Optimization in Cataract Surgery
An observational study of Cataract, run by The Eye Institute of West Florida at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Lacrifill Canalicular Filler
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2026to 15 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects aged 40 years or older with diagnosed dry eye disease, totaling 65 eyes enrolled.
Who may be able to join
- 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
Who cannot join
- Previous punctal plugs or canalicular cautery
- Active ocular inflammation or corneal pathology unrelated to DED
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Eye Institute of West Florida
Largo, Florida, 33770
Renee Bondurant, 727-450-4668, Renee.Bondurant@eyespecialist.com
Neel R Desai, MD
About this study
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
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).
- Conditions
- Cataract
- Being tested
- Lacrifill Canalicular Filler
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacrifill Canalicular FillerDevice
Lacrifill Canalicular Filler
| Study group | Role | What they receive |
|---|---|---|
| Lacrifill Canalicular Filler | Observational Study Receives: Device: Lacrifill Canalicular Filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month postoperatively
Secondary outcomes (4)
Difference in mean magnitude of postoperative refractive astigmatism
Measured: 1 month postoperatively
Lens type candidacy
Evaluation of patient eligibility for IOL based on improved ocular surface conditions and investigator medical judgement.
Measured: Preoperative assessment
Postoperative uncorrected visual acuity (logMAR)
Measured: 1 month postoperatively
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.
Measured: 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start22 Jul 2026
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Eye Institute of West Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Neel Desai, MD, Principal investigator, The Eye Institute of West Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648095
- Sponsor's protocol ID
- ND-26-01
- Status last verified
- Aug 2026
- First submitted
- 9 Jun 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07648095
- Acronym / sponsor ID
- ND-26-01
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- The Eye Institute of West FloridaUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lacrifill Canalicular Filler | – | Device: Lacrifill Canalicular FillerObservational Study |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged 40 years or older with diagnosed dry eye disease, totaling 65 eyes enrolled.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Previous punctal plugs or canalicular cautery
- Active ocular inflammation or corneal pathology unrelated to DED
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lacrifill Canalicular FillerLacrifill Canalicular Filler | Device | Lacrifill Canalicular Filler |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neel Desai, MD principal investigator
The Eye Institute of West Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by The Eye Institute of West Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renee Bondurant (727-450-4668, Renee.Bondurant@eyespecialist.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absolute error (MAE) (time frame: 1 month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.