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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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A single center, prospective, randomized, comparative study of visual field assessments between the TEMPO, VisuALL, and HFA perimeters. Subjects will be assessed at 1 visit. Clinical evaluations will include MD, PSD, FT, VFI, OCT, and a questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEMPO | Experimental | Visual field assessment with the TEMPO |
|
| Humphrey Field Analyzer | Active Comparator | Visual field assessment with the Humphrey Field Analyzer |
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| VisuALL | Active Comparator | Visual field assessment with the VisuALL |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual field assessment | Diagnostic Test | Automated perimetry |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Acquisition Time (Both Eyes) | The total time to complete automated perimetry in both eyes. | Visit 1 (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Deviation (MD) | visual field mean deviation (unit = decibels) | Visit 1 (Day 0) |
| Pattern Standard Deviation (PSD) | visual field pattern standard deviation (unit = decibels) PSD is a measure of visual field irregularity. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Field Index (VFI) | Visual field Index goes from 100% = perfect to 0% = no vision | Visit 1 (Day 0) |
| Setup Time | Total setup time was defined as the time from first instructions to each participant up to visual field acquisition start. |
Inclusion Criteria:
Exclusion Criteria:
The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clayton Blehm, MD | North Georgia Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Georgia Eye Associates | Gainesville | Georgia | 30501 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | First TEMPO, Then VisuALL, Then Humphrey Field Analyzer | Visual field assessment: Automated perimetry |
| FG001 | First TEMPO, Then Humphrey Field Analyzer, Then VisuALL | Visual field assessment: Automated perimetry |
| FG002 | First VisuALL, Then TEMPO, Then Humphrey Field Analyzer | Visual field assessment: Automated perimetry |
| FG003 | First VisuALL, Then Humphrey Field Analyzer, Then TEMPO | Visual field assessment: Automated perimetry |
| FG004 | First Humphrey Field Analyzer, Then TEMPO, Then VisuALL | Visual field assessment: Automated perimetry |
| FG005 | First Humphrey Field Analyzer, Then VisuALL, Then TEMPO | Visual field assessment: Automated perimetry |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| Third Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants received testing with all 3 devices. |
| 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 | Total Acquisition Time (Both Eyes) | The total time to complete automated perimetry in both eyes. | Posted | Mean | Standard Deviation | minutes | Visit 1 (Day 0) |
|
1 day
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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 | TEMPO | Visual field assessment with the TEMPO Visual field assessment: Automated perimetry |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clayton Blehm | North Georgia Eye Associates | +17705324444 | claytonblehm@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2024 | Feb 25, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Visit 1 (Day 0) |
| Foveal Threshold (FT) | visual field foveal threshold (unit = decibels) | Visit 1 (Day 0) |
| Patient Questionnaire | A series of 9 Likert style questions (Strongly Disagree to Strongly Agree) that patients answered about the comfort, ease of use, and anxiety with each device. Strongly Agree was considered a better outcome for comfort and ease of use questions, and Strongly Disagree was considered a better outcome for anxiety questions. | Visit 1 (Day 0) |
| Visit 1 (Day 0) |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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| Secondary | Mean Deviation (MD) | visual field mean deviation (unit = decibels) | Posted | Mean | Standard Deviation | dB | Visit 1 (Day 0) |
|
|
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| Secondary | Pattern Standard Deviation (PSD) | visual field pattern standard deviation (unit = decibels) PSD is a measure of visual field irregularity. | Posted | Mean | Standard Deviation | dB | Visit 1 (Day 0) |
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|
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| Secondary | Foveal Threshold (FT) | visual field foveal threshold (unit = decibels) | Posted | Mean | Standard Deviation | dB | Visit 1 (Day 0) |
|
|
|
| Secondary | Patient Questionnaire | A series of 9 Likert style questions (Strongly Disagree to Strongly Agree) that patients answered about the comfort, ease of use, and anxiety with each device. Strongly Agree was considered a better outcome for comfort and ease of use questions, and Strongly Disagree was considered a better outcome for anxiety questions. | Posted | Count of Participants | Participants | Visit 1 (Day 0) |
|
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| Other Pre-specified | Visual Field Index (VFI) | Visual field Index goes from 100% = perfect to 0% = no vision | Posted | Mean | Standard Deviation | percentage | Visit 1 (Day 0) |
|
|
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| Other Pre-specified | Setup Time | Total setup time was defined as the time from first instructions to each participant up to visual field acquisition start. | Posted | Mean | Standard Deviation | minutes | Visit 1 (Day 0) |
|
|
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| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Humphrey Field Analyzer | Visual field assessment with the Humphrey Field Analyzer Visual field assessment: Automated perimetry | 0 | 54 | 0 | 54 | 0 | 54 |
| EG002 | VisuALL | Visual field assessment with the VisuALL Visual field assessment: Automated perimetry | 0 | 54 | 0 | 54 | 0 | 54 |
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| Caused Anxiety (%) "Disagree" or "Strongly Disagree" |
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