Open Angle GlaucomaNCT05955118
Hydrus Microstent as a Quality of Life Consideration
An observational study of Open Angle Glaucoma, run by InSight Vision Center Medical Group, Inc at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Hydrus Microstent
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with mild to moderate OAG undergoing bilateral combined cataract surgery \& Hydrus Microstent implantation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Terri Smith
Fresno, California, 93720
Terri Smith, 559-449-5050
Eric Poulsen, MD
About this study
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.
Read the 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.
- Conditions
- Open Angle Glaucoma
- Being tested
- Hydrus Microstent
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrus MicrostentDevice
Hydrus Microstent placed at the time of cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Open Angle Glaucoma | Subjects with mild to moderate open angle glaucoma undergoing bilateral combined cataract surgery \& Hydrus Microstent implantation. Receives: Device: Hydrus Microstent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (2)
Number of Medication Reduction for Glaucoma
The number of glaucoma medications used before the intervention are compared to the number used after.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 Apr 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InSight Vision Center Medical Group, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Poulsen, InSight Vision Center Medical Group, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955118
- Sponsor's protocol ID
- HQoL-23
- Status last verified
- Jul 2023
- First submitted
- 25 May 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Journal publication. Congress presentation.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrus Microstent as a Quality of Life Consideration
- ClinicalTrials.gov ID
- NCT05955118
- Acronym / sponsor ID
- HQoL-23
- Conditions
- Open Angle Glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- InSight Vision Center Medical Group, IncUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Angle Glaucoma | – | Device: Hydrus MicrostentSubjects with mild to moderate open angle glaucoma undergoing bilateral combined cataract surgery \& Hydrus Microstent implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with mild to moderate OAG undergoing bilateral combined cataract surgery \& Hydrus Microstent implantation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrus MicrostentHydrus Microstent placed at the time of cataract surgery | Device | Open Angle Glaucoma |
Primary outcome
Change in Glaucoma Symptom Score (GSS) Score
Time frame: 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).
2 secondary outcomes
Number of Medication Reduction for Glaucoma
Time frame: 3 months
Ocular surface disease (OSD) assessment
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Individual participant dataSharing planned: Undecided. Journal publication. Congress presentation.
Related trials for Open Angle Glaucoma
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Angle Glaucoma, run by InSight Vision Center Medical Group, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Terri Smith (5594495050, tsmith@insightvisioncenter.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glaucoma Symptom Score (GSS) Score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.