Hydrus Microstent as a Quality of Life Consideration

InSight Vision Center Medical Group, Inc

Status

Enrolling

Conditions

Open Angle Glaucoma

Treatments

Device: Hydrus Microstent

Study type

Observational

Funder types

Other

Identifiers

NCT05955118

HQoL-23

Details and patient eligibility

About

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.

Full description

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.

Enrollment

38 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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