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The study aims to identify if Hydrus microstent implantation in patients with open angle glaucoma (OAG) at the time of cataract surgery improves quality of life for patients and explore what quality of life factors motivate patients.
Prospective, interventional single arm study of patient-reported outcomes (PRO) via GSS with pre and post ocular surface disease assessment in subjects undergoing bilateral phaco and Hydrus implantation; Study will also explore other QOL factors that may motivate patients to accept Hydrus via Glauc-QOL36 and customized questions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Angle Glaucoma | Subjects with mild to moderate open angle glaucoma undergoing bilateral combined cataract surgery & Hydrus Microstent implantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrus Microstent | Device | Hydrus Microstent placed at the time of cataract surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glaucoma Symptom Score (GSS) Score | GSS is a cross-sectional study of symptoms, functional impairment, and vision-targeted health-related quality of life among persons with glaucoma, scored 0-100, with a higher score being more favorable (ie fewer adverse symptoms). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Medication Reduction for Glaucoma | The number of glaucoma medications used before the intervention are compared to the number used after. | 3 months |
| Ocular surface disease (OSD) assessment |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with mild to moderate OAG undergoing bilateral combined cataract surgery & Hydrus Microstent implantation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Terri Smith | Contact | 5594495050 | tsmith@insightvisioncenter.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Terri Smith | Recruiting | Fresno | California | 93720 | United States |
Journal publication. Congress presentation.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 9, 2023 | May 25, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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The Oxford Grading System is used to grade the amount of corneal and conjunctival fluorescein staining, scored 0 (none) to V.
| 3 months |