Hydrus Microstent as a Quality of Life Consideration

Open Angle Glaucoma Clinical Trial

Official title:

Hydrus Microstent as a Quality of Life Consideration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05955118
• Other study ID #: HQoL-23
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: July 2023
• Source: InSight Vision Center Medical Group, Inc
• Contact: Terri Smith
• Phone: 5594495050
• Email: tsmith[@]insightvisioncenter.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Open Angle Glaucoma

Intervention

Device:
• Hydrus Microstent
Hydrus Microstent placed at the time of cataract surgery

Locations

Country	Name	City	State
United States	Terri Smith	Fresno	California

Sponsors (1)

Lead Sponsor	Collaborator
InSight Vision Center Medical Group, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Medication Reduction for Glaucoma	The number of glaucoma medications used before the intervention are compared to the number used after.	3 months
Secondary	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