Status:
RECRUITING
Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of DED in Patients Undergoing Cataract Surgery
Lead Sponsor:
Vance Thompson Vision
Conditions:
Dry Eye Disease (DED)
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
To review how patients report using a hyaluronate crosslinked canalicular gel placed before cataract surgery
Detailed Description
Prospective, single-site, single-arm study enrolling 60 patients who have elected advanced IOL implantation at the time of cataract surgery and have a diagnosis of dry eye disease. The study will cons...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07155057
Start Date
September 3 2025
End Date
December 1 2026
Last Update
September 29 2025
Active Locations (1)
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1
Vance Thompson Vision Clinic, Prof. LLC
Sioux Falls, South Dakota, United States, 57105