RECRUITINGINTERVENTIONAL
Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of DED in Patients Undergoing 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
About This Trial
To review how patients report using a hyaluronate crosslinked canalicular gel placed before cataract surgery
Who May Be Eligible (Plain English)
Who May Qualify:
- Be willing and able to understand and sign the willing to sign a consent form 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML
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 consist of 5 study visits, over a 3-5 month time period. Patients will receive bilateral lacrimal occlusion of crosslinked hyaluronate canalicular gel pre-operatively
Locations (1)
Vance Thompson Vision Clinic, Prof. LLC
Sioux Falls, South Dakota, United States