Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of DED in Patients Undergoing Cataract Surgery

Vance Thompson Vision60 enrolled

Overview

To review how patients report using a hyaluronate crosslinked canalicular gel placed before cataract surgery

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Dry Eye Disease (DED)

Interventions

Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3MLDEVICE

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Vance Thompson Vision Clinic, Prof. LLC

Sioux Falls, South Dakota, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Tear Break-Up time. Tear breakup time (TBUT) is a clinical measurement that assesses the stability of the tear film on the surface of the eye. It measures the time it takes for dry spots to form on the cornea after a complete blink. A rapid breakup indicates tear film instability, which is a common cause of dry eye syndrome. Interpreting TBUT results: A person's TBUT score is an indicator of their tear film health. Normal: A TBUT of 10 seconds or more typically signifies a healthy and stable tear film. Marginal/Mild to Moderate Instability: A score of 5 to 9 seconds may suggest mild to moderate tear film instability. Low/Dry Eye: A score of less than 5 seconds is a strong indicator of dry eye syndrome caused by tear film dysfunction.

Time frame: 3 months

Central Contacts

Tiffany Facile

CONTACT

605-371-7075 tiffany.facile@vancethompsonvision.com

Data from ClinicalTrials.gov

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