GlaucomaNCT05529966
Comparing NGENUITY vs Conventional Microscope in a New Hydrus User
A study testing NGENUITY and Conventional microscope in people with Glaucoma, run by Stanford University at 1 site in United States.
Trial summary
To compare the potential efficiency and educational value of using NGENUITY (3D camera system, FDA approved for this indication) vs the conventional microscope for Hydrus microstent placement by new users. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- NGENUITY and Conventional microscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2023to 22 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild to moderate primary open angle glaucoma as defined by AGS with visually significant age-related cataract undergoing uncomplicated cataract surgery and Hydrus microstent
- Either eye or both eyes may participate
Who cannot join
- Lack of patient cooperation severely affecting ability to place stent with any visualization technique
- Angle abnormalities including PAS in nasal quadrant
- Unable to properly visualize the angle due to complicated cataract surgery
Trial locations and contacts
1 site in 1 country.
About this study
To compare the potential efficiency and educational value of using NGENUITY (3D camera system, FDA approved for this indication) vs the conventional microscope for Hydrus microstent placement by new users.
- Conditions
- Glaucoma
- Being tested
- NGENUITY, Conventional microscope
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGENUITYDevice
Device for 3-D viewing during placement of micro-stent placement.
Conventional microscopeDevice
Device for stereoscopic viewing during placement of micro-stent placement.
| Study group | Role | What they receive |
|---|---|---|
| NGENUITY | Experimental | Research fellow participants utilize NGENUITY during micro-stent placement Receives: Device: NGENUITY |
| Conventional microscope | Active comparator | Research fellow participants utilize conventional microscope during micro-stent placement Receives: Device: Conventional microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out
Measured: up to 1 hour
Secondary outcomes (5)
Number of Trabecular Meshwork Piercing Attempts Needed to Place Stent
Measured: up to 1 hour
Number of Anterior Chamber Entry and Reentry Attempts During Stent Placement
Measured: up to 1 hour
Number of Microscope Focus or Position Readjustments Needed During Stent Placement
Measured: up to 1 hour
Change in Attending Questionnaire Score
Providers rate their comfort, visibility, image quality, focus, depth perception, staff engagement, teaching and level of confidence in using the system and system performance. Ratings are on a Likert scale of 1 to 5. Higher scores correspond to excellent ratings, higher confidence in using the system, and better system performance; for Scope Preference only, lower numbers (either group) correspond to a preference for NGenuity visualization.
Measured: Up to 5 minutes
Change in Fellow Questionnaire Score
Providers rate their comfort, visibility, image quality, focus, depth perception, staff engagement, teaching and level of confidence in using the system and system performance. Ratings are on a Likert scale of 1 to 5. Higher scores correspond to excellent ratings, higher confidence in using the system, and better system performance; for Scope Preference only, lower numbers (either group) correspond to a preference for NGenuity visualization.
Measured: Up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start13 Feb 2023
- Primary completion22 Mar 2024
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Robert T. Chang, MD, Stanford University
- Investigators
- Robert T Chang, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529966
- Sponsor's protocol ID
- 66363
- Status last verified
- Apr 2025
- First submitted
- 2 Sep 2022
- Last updated
- 17 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing NGENUITY vs Conventional Microscope in a New Hydrus User
- ClinicalTrials.gov ID
- NCT05529966
- Acronym / sponsor ID
- 66363
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Posted 8 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the potential efficiency and educational value of using NGENUITY (3D camera system, FDA approved for this indication) vs the conventional microscope for Hydrus microstent placement by new users.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NGENUITY | Experimental | Device: NGENUITYResearch fellow participants utilize NGENUITY during micro-stent placement |
| Conventional microscope | Active comparator | Device: Conventional microscopeResearch fellow participants utilize conventional microscope during micro-stent placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with mild to moderate primary open angle glaucoma as defined by AGS with visually significant age-related cataract undergoing uncomplicated cataract surgery and Hydrus microstent
- Either eye or both eyes may participate
Key exclusion criteria (3 listed)
- Lack of patient cooperation severely affecting ability to place stent with any visualization technique
- Angle abnormalities including PAS in nasal quadrant
- Unable to properly visualize the angle due to complicated cataract surgery
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 |
|---|---|---|
| NGENUITYDevice for 3-D viewing during placement of micro-stent placement. | Device | NGENUITY |
| Conventional microscopeDevice for stereoscopic viewing during placement of micro-stent placement. | Device | Conventional microscope |
Primary outcome
Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out
Time frame: up to 1 hour
5 secondary outcomes
Number of Trabecular Meshwork Piercing Attempts Needed to Place Stent
Time frame: up to 1 hour
Number of Anterior Chamber Entry and Reentry Attempts During Stent Placement
Time frame: up to 1 hour
Number of Microscope Focus or Position Readjustments Needed During Stent Placement
Time frame: up to 1 hour
Change in Attending Questionnaire Score
Time frame: Up to 5 minutes
Change in Fellow Questionnaire Score
Time frame: Up to 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Robert T Chang, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NGENUITY and Conventional microscope in people with Glaucoma, run by Stanford University 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 17 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out (time frame: up to 1 hour). 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 17 Apr 2025.