Recruiting

Hydrus MicrostentHydrus Microstent as a Quality of Life Consideration

Sponsor:

InSight Vision Center Medical Group, Inc

Code:

NCT05955118

Conditions

Open Angle Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Hydrus Microstent

Study Details

Brief summary:

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.

Conditions

Open Angle Glaucoma

Study ID

NCT05955118

Start date

Apr 1, 2023

Status verified date

Jul, 2023

Completion date

Apr 1, 2024

Anticipated

Primary completion date

Apr 1, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Clinical diagnosis of mild to moderate open angle glaucoma as defined by with visually significant age-related cataract undergoing uncomplicated cataract surgery and Hydrus Microstent
Current treatment with one or more ocular hypotensive medication
Corneal thickness between 470 to 610µm
Potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 LogMAR (20/25) postoperatively

Exclusion Criteria:

Clinical diagnosis of secondary glaucoma (traumatic, neovascular, mixed-mechanism, uveitic glaucoma)
corneal opacity or angle abnormalities that make visualizing the angle difficult
Past ocular surgery
History of ocular, systemic medications, or systemic diseases/co-morbidities that significantly impact on quality of life or vision (e.g. advanced macular degeneration, autoimmune diseases, mental illness/depression, uncontrolled systemic disease on polypharmacy)
Severe dry eye requiring secretagogues, serum eyedrops, topical corticosteroids, amniotic membrane grafts

Study Design

Enrollment

38 participants

Anticipated

Interventions and Outcome Measures

Arms

Open Angle Glaucoma

Subjects with mild to moderate open angle glaucoma undergoing bilateral combined cataract surgery \& Hydrus Microstent implantation.

Interventions

Hydrus Microstent

Hydrus Microstent placed at the time of cataract surgery

Primary outcome measure

Change in Glaucoma Symptom Score (GSS) Score [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Terri Smith

5594495050 tsmith@insightvisioncenter.com

Locations

Terri Smith

Recruiting

Fresno, California, United States, 93720

Contacts

Terri Smith

559-449-5050

Principal Investigator:

Eric Poulsen, MD

More Information

Sponsor

InSight Vision Center Medical Group, Inc

Last update posted

Jul 21, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by InSight Vision Center Medical Group, Inc on 2023-07-21.