Hydrus Microstent as a Quality of Life Consideration

Recruiting

• Conditions: Open Angle Glaucoma
• Interventions: Device: Hydrus Microstent

• Registration Number: NCT05955118
• Lead Sponsor: InSight Vision Center Medical Group, Inc

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.

Detailed 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.

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-05-25
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-12
• Last Update Submitted: 2023-07-12
• Study First Posted: 2023-07-21
• Last Update Posted: 2023-07-21
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open Angle Glaucoma	Hydrus Microstent	Subjects with mild to moderate open angle glaucoma undergoing bilateral combined cataract surgery \& Hydrus Microstent implantation.

Primary Outcome Measures

Name	Time	Method
Change in Glaucoma Symptom Score (GSS) Score	3 months	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).

Secondary Outcome Measures

Name	Time	Method
Number of Medication Reduction for Glaucoma	3 months	The number of glaucoma medications used before the intervention are compared to the number used after.
Ocular surface disease (OSD) assessment	3 months	The Oxford Grading System is used to grade the amount of corneal and conjunctival fluorescein staining, scored 0 (none) to V.

Trial Locations

Locations (1)

Terri Smith; 🇺🇸 Fresno, California, United States