Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Participants | Other | Patients will receive bilateral lacrimal occlusion of crosslinked hyaluronate canalicular gel pre-operatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiffany Facile | Contact | 605-371-7075 | tiffany.facile@vancethompsonvision.com |
| Name | Affiliation | Role |
|---|---|---|
| Kayla Karpuk, OD | Vance Thompson Vision Clinic Prof. LLC | Principal Investigator |
| Vance Thompson, MD | Vance Thompson Vision Clinic Prof. LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vance Thompson Vision Clinic, Prof. LLC | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 12, 2025 | Sep 4, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 12, 2025 | Sep 4, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|