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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-03

Study Completion Date

2026-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Dry Eye Disease (DED)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Study Participants

Patients will receive bilateral lacrimal occlusion of crosslinked hyaluronate canalicular gel pre-operatively

Group Type OTHER

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

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes