Crosslinked hyaluronate gel to help dry eye during cataract surgery
A Prospective, Single-Arm Study Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of Dry Eye Disease in Patients Undergoing Refractive Cataract Surgery
This tests whether putting a crosslinked hyaluronate canalicular gel to block the tear ducts before cataract surgery helps people with dry eye disease who are getting advanced intraocular lenses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Vance Thompson Vision Academic / other |
| Locations | 1 site (Sioux Falls, South Dakota) |
| Trial ID | NCT07155057 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-site, single-arm study enrolling 60 patients with dry eye disease who have chosen advanced intraocular lens implantation at the time of cataract surgery. Participants will receive bilateral lacrimal occlusion with a crosslinked hyaluronate canalicular gel placed preoperatively. The study includes five visits over a 3–5 month period to capture patient-reported use and outcomes. Data will focus on symptom reporting and tolerability around the surgical period.
Who should consider this trial
Good fit: Ideal candidates are adults (22 or older) with diagnosed dry eye disease (OSDI ≥13 and tear break-up time ≤10 seconds in at least one eye) who are electing advanced technology lens implants and can attend study visits.
Not a fit: Patients with prior punctal cautery, obstructive lacrimal anatomy, or who are not receiving advanced IOLs (or cannot travel to the study site) may not receive benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could reduce dry eye symptoms around cataract surgery and improve comfort and visual outcomes after advanced IOL implantation.
How similar studies have performed: Punctal occlusion is an established treatment for dry eye, but using a crosslinked hyaluronate canalicular gel is a newer, less-studied method compared with traditional plugs or cautery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be willing and able to understand and sign the informed consent form (ICF) * Men or non-pregnant women age 22 or older * Clear intraocular media other than cataract * Diagnosis of dry eye disease (OSDI score ≥ 13) * Non-invasive Tear break up time ≤ 10 seconds in at least one eye * Willing and able to comply with all study related visits and procedures * In the opinion of the investigator, patients who are appropriate for advanced technology lens implants Exclusion Criteria: * History of punctal cautery * Lacrimal anatomy (e.g., nasolacrimal duct obstruction) that per investigator suggests that the patient would not be a good candidate for lacrimal occlusion or patients for whom lacrimal occlusion would increase risk
Where this trial is running
Sioux Falls, South Dakota
- Vance Thompson Vision Clinic, Prof. LLC — Sioux Falls, South Dakota, United States (Recruiting)
Study contacts
- Principal investigator: Kayla Karpuk, OD — Vance Thompson Vision Clinic Prof. LLC
- Study coordinator: Tiffany Facile
- Email: tiffany.facile@vancethompsonvision.com
- Phone: 605-371-7075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.