Hydrus Microstent as a Quality of Life Consideration

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.

Study Overview

• Status: Recruiting
• Conditions: Open Angle Glaucoma
• Intervention / Treatment: Device: Hydrus Microstent

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 Type: Observational
• Enrollment (Estimated): 38

Contacts and Locations

• Study Contact: Name: Terri Smith; Phone Number: 5594495050; Email: tsmith@insightvisioncenter.com

Study Locations

• United States
  • California
    • Fresno, California, United States, 93720
      • Recruiting
      • Terri Smith
      • Contact: Terri Smith; Phone Number: 559-449-5050
      • Principal Investigator: Eric Poulsen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects with mild to moderate OAG undergoing bilateral combined cataract surgery & Hydrus Microstent implantation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Open Angle Glaucoma; Subjects with mild to moderate open angle glaucoma undergoing bilateral combined cataract surgery & Hydrus Microstent implantation.	Device: Hydrus Microstent; Hydrus Microstent placed at the time of cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	The Oxford Grading System is used to grade the amount of corneal and conjunctival fluorescein staining, scored 0 (none) to V.	3 months

Collaborators and Investigators

• Sponsor: InSight Vision Center Medical Group, Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: HQoL-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Journal publication. Congress presentation.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No