Glaucoma
Conditions
Brief 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.
Interventions
DEVICENGENUITY
Device for 3-D viewing during placement of micro-stent placement.
DEVICEConventional microscope
Device for stereoscopic viewing during placement of micro-stent placement.
Sponsors
Alcon Research
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out | up to 1 hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Trabecular Meshwork Piercing Attempts Needed to Place Stent | up to 1 hour | — |
| Number of Anterior Chamber Entry and Reentry Attempts During Stent Placement | up to 1 hour | — |
| Number of Microscope Focus or Position Readjustments Needed During Stent Placement | up to 1 hour | — |
| Change in Attending Questionnaire Score | Up to 5 minutes | 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. |
| Change in Fellow Questionnaire Score | Up to 5 minutes | 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. |
Countries
United States
Participant flow
Pre-assignment details
32 participants signed informed consent, 28 were randomized to either study arm.
Participants by arm
| Arm | Count |
|---|---|
| Conventional Microscope Participants randomized to the use of a conventional microscope for the first eye procedure. Participants who had a procedure for their second eye were randomized again to either the conventional or NGENUITY microscope. | 12 |
| NGENUITY Participants randomized to the use of a NGENUITY microscope for the first eye procedure. Participants who had a procedure for their second eye were randomized again to either the conventional or NGENUITY microscope. | 13 |
| Total | 25 |
Baseline characteristics
| Characteristic | NGENUITY | Total | Conventional Microscope |
|---|---|---|---|
| Age, Continuous | 76.1 years STANDARD_DEVIATION 7.3 | 75.9 years STANDARD_DEVIATION 7.5 | 75.6 years STANDARD_DEVIATION 8.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 24 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 8 Participants | 6 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 9 Participants | 13 Participants | 4 Participants |
| Region of Enrollment United States | 13 Participants | 25 Participants | 12 Participants |
| Sex: Female, Male Female | 6 Participants | 13 Participants | 7 Participants |
| Sex: Female, Male Male | 7 Participants | 12 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 | 0 / 1 | 0 / 3 |
| other Total, other adverse events | 0 / 14 | 0 / 14 | 0 / 1 | 0 / 3 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 1 | 0 / 3 |
Outcome results
Primary
Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out
Time frame: up to 1 hour
Population: Participants/eyes evaluable for primary and secondary outcome measure analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Microscope | Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out | 2.55 minutes | Standard Deviation 1.36 |
| NGENUITY | Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out | 3.06 minutes | Standard Deviation 2.17 |
p-value: 0.45490734t-test, 2 sided
Secondary
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.
Time frame: Up to 5 minutes
Population: Participants/eyes evaluable for primary and secondary outcome measure analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Microscope | Change in Attending Questionnaire Score | Comfort | 3.14 score on a scale | Standard Deviation 0.53 |
| Conventional Microscope | Change in Attending Questionnaire Score | Visibility | 3.57 score on a scale | Standard Deviation 0.85 |
| Conventional Microscope | Change in Attending Questionnaire Score | Image Quality | 3.14 score on a scale | Standard Deviation 0.77 |
| Conventional Microscope | Change in Attending Questionnaire Score | Focus | 3.14 score on a scale | Standard Deviation 0.66 |
| Conventional Microscope | Change in Attending Questionnaire Score | Depth Perception | 2.93 score on a scale | Standard Deviation 0.73 |
| Conventional Microscope | Change in Attending Questionnaire Score | Staff Engagement | 3.36 score on a scale | Standard Deviation 0.5 |
| Conventional Microscope | Change in Attending Questionnaire Score | Teaching | 3.29 score on a scale | Standard Deviation 0.73 |
| Conventional Microscope | Change in Attending Questionnaire Score | En Face Confidence | 3.43 score on a scale | Standard Deviation 0.51 |
| Conventional Microscope | Change in Attending Questionnaire Score | Hydrus Placement Confidence | 3.71 score on a scale | Standard Deviation 0.47 |
| Conventional Microscope | Change in Attending Questionnaire Score | Scope Preference (1 = 3D.) | 2.71 score on a scale | Standard Deviation 0.61 |
| NGENUITY | Change in Attending Questionnaire Score | En Face Confidence | 4.07 score on a scale | Standard Deviation 0.96 |
| NGENUITY | Change in Attending Questionnaire Score | Comfort | 3.93 score on a scale | Standard Deviation 0.8 |
| NGENUITY | Change in Attending Questionnaire Score | Staff Engagement | 4.27 score on a scale | Standard Deviation 0.8 |
| NGENUITY | Change in Attending Questionnaire Score | Visibility | 4.53 score on a scale | Standard Deviation 0.64 |
| NGENUITY | Change in Attending Questionnaire Score | Scope Preference (1 = 3D.) | 1.80 score on a scale | Standard Deviation 0.86 |
| NGENUITY | Change in Attending Questionnaire Score | Image Quality | 4.6 score on a scale | Standard Deviation 0.74 |
| NGENUITY | Change in Attending Questionnaire Score | Teaching | 4.67 score on a scale | Standard Deviation 0.62 |
| NGENUITY | Change in Attending Questionnaire Score | Focus | 4.0 score on a scale | Standard Deviation 1.25 |
| NGENUITY | Change in Attending Questionnaire Score | Hydrus Placement Confidence | 4.20 score on a scale | Standard Deviation 1.08 |
| NGENUITY | Change in Attending Questionnaire Score | Depth Perception | 4.67 score on a scale | Standard Deviation 0.62 |
Comparison: Analysis of comfort scorep-value: 0.0042494t-test, 2 sided
Comparison: Analysis of Visibility scorep-value: 0.00223547t-test, 2 sided
Comparison: Analysis of Image Quality scorep-value: 0.00001858t-test, 2 sided
Comparison: Analysis of Focus scorep-value: 0.03003194t-test, 2 sided
Comparison: Analysis of Depth Perception scorep-value: 2.8e-7t-test, 2 sided
Comparison: Analysis of Staff Engagement scorep-value: 0.00112148t-test, 2 sided
Comparison: Analysis of Teaching scorep-value: 951t-test, 2 sided
Comparison: Analysis of En Face Confidence scorep-value: 0.03493564t-test, 2 sided
Comparison: Analysis of Hydrus Placement Confidence scorep-value: 0.12895248t-test, 2 sided
Comparison: Analysis of Scope Preference scorep-value: 0.00279611t-test, 2 sided
Secondary
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.
Time frame: Up to 5 minutes
Population: Participants/eyes evaluable for primary and secondary outcome measure analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Microscope | Change in Fellow Questionnaire Score | Image Quality | 4.21 score on a scale | Standard Deviation 0.8 |
| Conventional Microscope | Change in Fellow Questionnaire Score | Staff Engagement | 3.57 score on a scale | Standard Deviation 0.94 |
| Conventional Microscope | Change in Fellow Questionnaire Score | Teaching | 4.00 score on a scale | Standard Deviation 0.78 |
| Conventional Microscope | Change in Fellow Questionnaire Score | Visibility | 4.21 score on a scale | Standard Deviation 0.8 |
| Conventional Microscope | Change in Fellow Questionnaire Score | En Face Confidence | 4.00 score on a scale | Standard Deviation 0.88 |
| Conventional Microscope | Change in Fellow Questionnaire Score | Focus | 3.93 score on a scale | Standard Deviation 0.83 |
| Conventional Microscope | Change in Fellow Questionnaire Score | Hydrus Placement Confidence | 4.29 score on a scale | Standard Deviation 0.61 |
| Conventional Microscope | Change in Fellow Questionnaire Score | Comfort | 4.21 score on a scale | Standard Deviation 0.89 |
| Conventional Microscope | Change in Fellow Questionnaire Score | Scope Preference (1 = 3D..) | 3.00 score on a scale | Standard Deviation 1.11 |
| Conventional Microscope | Change in Fellow Questionnaire Score | Depth Perception | 4.29 score on a scale | Standard Deviation 0.61 |
| NGENUITY | Change in Fellow Questionnaire Score | Scope Preference (1 = 3D..) | 1.93 score on a scale | Standard Deviation 1.1 |
| NGENUITY | Change in Fellow Questionnaire Score | Comfort | 4.20 score on a scale | Standard Deviation 0.56 |
| NGENUITY | Change in Fellow Questionnaire Score | Visibility | 4.60 score on a scale | Standard Deviation 0.83 |
| NGENUITY | Change in Fellow Questionnaire Score | Image Quality | 4.60 score on a scale | Standard Deviation 0.83 |
| NGENUITY | Change in Fellow Questionnaire Score | Focus | 4.40 score on a scale | Standard Deviation 0.91 |
| NGENUITY | Change in Fellow Questionnaire Score | Depth Perception | 4.73 score on a scale | Standard Deviation 0.59 |
| NGENUITY | Change in Fellow Questionnaire Score | Teaching | 4.80 score on a scale | Standard Deviation 0.56 |
| NGENUITY | Change in Fellow Questionnaire Score | En Face Confidence | 4.33 score on a scale | Standard Deviation 0.82 |
| NGENUITY | Change in Fellow Questionnaire Score | Hydrus Placement Confidence | 4.53 score on a scale | Standard Deviation 0.83 |
| NGENUITY | Change in Fellow Questionnaire Score | Staff Engagement | 4.73 score on a scale | Standard Deviation 0.59 |
Comparison: Analysis of Comfort scorep-value: 0.959638658t-test, 2 sided
Comparison: Analysis of Visibility scorep-value: 0.213464715t-test, 2 sided
Comparison: Analysis of Image Quality scorep-value: 0.213464715t-test, 2 sided
Comparison: Analysis of Focus scorep-value: 0.155899777t-test, 2 sided
Comparison: Analysis of Depth Perception scorep-value: 0.055960023t-test, 2 sided
Comparison: Analysis of Staff Engagement scorep-value: 0.000685499t-test, 2 sided
Comparison: Analysis of Teaching scorep-value: 0.004526118t-test, 2 sided
Comparison: Analysis of En Face Confidence scorep-value: 0.299921137t-test, 2 sided
Comparison: Analysis of Hydrus Placement Confidence scorep-value: 0.368082084t-test, 2 sided
Comparison: Analysis of Scope Preference scorep-value: 0.015036417t-test, 2 sided
Secondary
Number of Anterior Chamber Entry and Reentry Attempts During Stent Placement
Time frame: up to 1 hour
Population: Participants/eyes evaluable for primary and secondary outcome measure analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Microscope | Number of Anterior Chamber Entry and Reentry Attempts During Stent Placement | 1.14 Number of Anterior Chamber Entries | Standard Deviation 0.36 |
| NGENUITY | Number of Anterior Chamber Entry and Reentry Attempts During Stent Placement | 1.13 Number of Anterior Chamber Entries | Standard Deviation 0.35 |
p-value: 0.94342221t-test, 2 sided
Secondary
Number of Microscope Focus or Position Readjustments Needed During Stent Placement
Time frame: up to 1 hour
Population: Participants/eyes evaluable for primary and secondary outcome measure analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Microscope | Number of Microscope Focus or Position Readjustments Needed During Stent Placement | 1.43 Number of Focus/Microscope adjustments | Standard Deviation 1.28 |
| NGENUITY | Number of Microscope Focus or Position Readjustments Needed During Stent Placement | 1.93 Number of Focus/Microscope adjustments | Standard Deviation 1.79 |
p-value: 0.38902793t-test, 2 sided
Secondary
Number of Trabecular Meshwork Piercing Attempts Needed to Place Stent
Time frame: up to 1 hour
Population: Participants/eyes evaluable for primary and secondary outcome measure analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Microscope | Number of Trabecular Meshwork Piercing Attempts Needed to Place Stent | 1.50 piercing | Standard Deviation 0.94 |
| NGENUITY | Number of Trabecular Meshwork Piercing Attempts Needed to Place Stent | 1.53 piercing | Standard Deviation 0.92 |
p-value: 0.9237611t-test, 2 sided