Hydrus Microstent as a Quality of Life Consideration
1 other identifier
observational
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2023
CompletedFirst Submitted
Initial submission to the registry
May 25, 2023
CompletedFirst Posted
Study publicly available on registry
July 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedJuly 21, 2023
July 1, 2023
1 year
May 25, 2023
July 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of Medication Reduction for Glaucoma
3 months
Ocular surface disease (OSD) assessment
3 months
Study Arms (1)
Open Angle Glaucoma
Subjects with mild to moderate open angle glaucoma undergoing bilateral combined cataract surgery \& Hydrus Microstent implantation.
Interventions
Eligibility Criteria
Subjects with mild to moderate OAG undergoing bilateral combined cataract surgery \& Hydrus Microstent implantation
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Terri Smith
Fresno, California, 93720, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ophthalmologist
Study Record Dates
First Submitted
May 25, 2023
First Posted
July 21, 2023
Study Start
April 1, 2023
Primary Completion
April 1, 2024
Study Completion
April 1, 2024
Last Updated
July 21, 2023
Record last verified: 2023-07