Hydrus Microstent as a Quality of Life Consideration

NCT ID: NCT05955118

Last Updated: 2023-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-04-01

Brief Summary

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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

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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.

Conditions

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Open Angle Glaucoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Open Angle Glaucoma

Subjects with mild to moderate open angle glaucoma undergoing bilateral combined cataract surgery \& Hydrus Microstent implantation.

Hydrus Microstent

Intervention Type DEVICE

Hydrus Microstent placed at the time of cataract surgery

Interventions

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Hydrus Microstent

Hydrus Microstent placed at the time of cataract surgery

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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InSight Vision Center Medical Group, Inc

OTHER

Sponsor Role lead

Responsible Party

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Eric Poulsen

Ophthalmologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Terri Smith

Fresno, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Terri Smith

Role: CONTACT

5594495050

Facility Contacts

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Terri Smith

Role: primary

559-449-5050

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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HQoL-23

Identifier Type: -

Identifier Source: org_study_id

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