A Prospective, Single-Arm Study Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of Dry Eye Disease in Patients Undergoing Refractive Cataract Surgery
Not Applicable
Not yet recruiting
- Conditions
- Dry Eye Disease (DED)
- Registration Number
- NCT07155057
- Lead Sponsor
- Vance Thompson Vision
- Brief Summary
To review how patients report using a hyaluronate crosslinked canalicular gel placed before cataract surgery
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change from baseline to 3- month visit in non-invasive tear break up time (NITBUT) in primary eyes as measured by a non-invasive, automated ocular surface analyzer. 3 months
- Secondary Outcome Measures
Name Time Method