Actively Recruiting
A Prospective, Single-Arm Study Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of Dry Eye Disease in Patients Undergoing Refractive Cataract Surgery
Led by Vance Thompson Vision · Updated on 2025-09-29
60
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how patients respond to a special gel called crosslinked hyaluronate canalicular gel used to treat dry eye disease in those undergoing cataract surgery with advanced lens implants. The study is prospective and will take place at a single site, enrolling 60 patients who have dry eye disease and have chosen advanced intraocular lens implantation during their cataract procedure. Participants will receive the gel applied to both eyes before surgery to block tear drainage canals, which may help with dry eye symptoms. The study includes five visits over a period of 3 to 5 months. This is a single-arm study, meaning all participants receive the gel treatment, and there is no comparison group. During the study, patients will attend scheduled visits for assessments, including measuring tear stability using a non-invasive ocular surface analyzer. The primary outcome is the change in tear break-up time from baseline to three months after treatment. Researchers will monitor participants throughout the study to understand the gel's effects on dry eye disease in the context of cataract surgery.
CONDITIONS
Brief Title
Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of DED in Patients Undergoing Cataract Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with OSDI score 63 13
- Non-invasive tear break up time 64 10 seconds in at least one eye
- Willing and able to comply with all study related visits and procedures
- Suitable for advanced technology lens implants as judged by the investigator
You will not qualify if you...
- History of punctal cautery
- Lacrimal anatomy issues such as nasolacrimal duct obstruction that make lacrimal occlusion unsuitable or risky according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive bilateral lacrimal occlusion of crosslinked hyaluronate canalicular gel pre-operatively as part of the cataract surgery procedure.
1 visit (in-person)
Duration - 3 to 5 months
Participants are monitored through follow-up visits to assess treatment effects and eye health after surgery and gel implantation.
4 visits (in-person) over 3 to 5 months
Trial Site Locations
Total: 1 location
1
Vance Thompson Vision Clinic, Prof. LLC
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
Research Team
T
Tiffany Facile
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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