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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGENUITY | Experimental | Research fellow participants utilize NGENUITY during micro-stent placement |
|
| Conventional microscope | Active Comparator | Research fellow participants utilize conventional microscope during micro-stent placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGENUITY | Device | Device for 3-D viewing during placement of micro-stent placement. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out | up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert T Chang, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute | Palo Alto | California | 94303 | United States |
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32 participants signed informed consent, 28 were randomized to either study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Conventional Microscope (Re-randomized) | Participants who had a procedure for their second eye were re-randomized to use of a conventional microscope for the procedure. |
| FG003 | NGENUITY (Re-randomized) | Participants who had a procedure for their second eye were re-randomized to use of the NGENUITY microscope for the procedure. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Eye |
| ||||||||||||||||||||||
| Second Eye |
|
Participants/eyes evaluable for primary and secondary outcome measure analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | NGENUITY |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out | Participants/eyes evaluable for primary and secondary outcome measure analysis | Posted | Mean | Standard Deviation | minutes | up to 1 hour | Eyes | Eyes |
|
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert T. Chang, MD | Stanford University | 650-725-5743 | christyr@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 4, 2022 | Mar 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 14, 2025 | Mar 14, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Conventional microscope |
| Device |
Device for stereoscopic viewing during placement of micro-stent placement. |
|
| Number of Microscope Focus or Position Readjustments Needed During Stent Placement |
| 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. | 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. | Up to 5 minutes |
| Randomized to Use of Opposite Microscope for Second Eye Procedure |
|
| Evaluable for Primary and Secondary Outcome Measure Analysis |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
| Eyes |
|
|
|
| Secondary | Number of Trabecular Meshwork Piercing Attempts Needed to Place Stent | Participants/eyes evaluable for primary and secondary outcome measure analysis | Posted | Mean | Standard Deviation | piercing | up to 1 hour | Eyes | Eyes |
|
|
|
|
| Secondary | Number of Anterior Chamber Entry and Reentry Attempts During Stent Placement | Participants/eyes evaluable for primary and secondary outcome measure analysis | Posted | Mean | Standard Deviation | Number of Anterior Chamber Entries | up to 1 hour | Eyes | Eyes |
|
|
|
|
| Secondary | Number of Microscope Focus or Position Readjustments Needed During Stent Placement | Participants/eyes evaluable for primary and secondary outcome measure analysis | Posted | Mean | Standard Deviation | Number of Focus/Microscope adjustments | up to 1 hour | Eyes | Eyes |
|
|
|
|
| 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. | Participants/eyes evaluable for primary and secondary outcome measure analysis | Posted | Mean | Standard Deviation | score on a scale | Up to 5 minutes | Eyes | Eyes |
|
|
|
|
| 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. | Participants/eyes evaluable for primary and secondary outcome measure analysis | Posted | Mean | Standard Deviation | score on a scale | Up to 5 minutes | Eyes | Eyes |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | Conventional Microscope (Re-randomized) | Participants who had a procedure for their second eye were re-randomized to use of a conventional microscope for the procedure. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG003 | NGENUITY (Re-randomized) | Participants who had a procedure for their second eye were re-randomized to use of the NGENUITY microscope for the procedure. | 0 | 3 | 0 | 3 | 0 | 3 |
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| Image Quality |
|
| Focus |
|
| Depth Perception |
|
| Staff Engagement |
|
| Teaching |
|
| En Face Confidence |
|
| Hydrus Placement Confidence |
|
| Scope Preference (1 = 3D.) |
|
| t-test, 2 sided |
| .00223547 |
The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 |
| Other |
| Analysis of Image Quality score | t-test, 2 sided | .00001858 | The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 | Other |
| Analysis of Focus score | t-test, 2 sided | .03003194 | The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 | Other |
| Analysis of Depth Perception score | t-test, 2 sided | .00000028 | The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 | Other |
| Analysis of Staff Engagement score | t-test, 2 sided | .00112148 | The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 | Other |
| Analysis of Teaching score | t-test, 2 sided | 00000951 | The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 | Other |
| Analysis of En Face Confidence score | t-test, 2 sided | .03493564 | The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 | Other |
| Analysis of Hydrus Placement Confidence score | t-test, 2 sided | .12895248 | The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 | Other |
| Analysis of Scope Preference score | t-test, 2 sided | .00279611 | The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 | Other |
| Image Quality |
|
| Focus |
|
| Depth Perception |
|
| Staff Engagement |
|
| Teaching |
|
| En Face Confidence |
|
| Hydrus Placement Confidence |
|
| Scope Preference (1 = 3D..) |
|
| t-test, 2 sided |
| .213464715 |
The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 |
| Other |
| Analysis of Image Quality score | t-test, 2 sided | .213464715 | The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 | Other |
| Analysis of Focus score | t-test, 2 sided | .155899777 | The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 | Other |
| Analysis of Depth Perception score | t-test, 2 sided | .055960023 | The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 | Other |
| Analysis of Staff Engagement score | t-test, 2 sided | .000685499 | The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 | Other |
| Analysis of Teaching score | t-test, 2 sided | .004526118 | The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 | Other |
| Analysis of En Face Confidence score | t-test, 2 sided | .299921137 | The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 | Other |
| Analysis of Hydrus Placement Confidence score | t-test, 2 sided | .368082084 | The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 | Other |
| Analysis of Scope Preference score | t-test, 2 sided | .015036417 | The a priori threshold for statistical significance after Bonferroni correction is < 0.002083333 | Other |