Crosslinked hyaluronate gel to help dry eye during cataract surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.