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This is a randomized prospective study of post-operative surgical outcomes and complication rates in patients with a Baerveldt 350 implant vs the Ahmed ClearPath implant. Each subject will be randomized to the Baerveldt group or ClearPath group at the time of consent for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baerveldt 350 implant | Active Comparator |
| |
| Ahmed ClearPath 350 implant | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baerveldt 350 implant | Device | The Baerveldt implant is an FDA-approved silicone, non-valved implant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) | Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1 | |
| Number of Participants Who Experienced a Complication | Up to Year 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) | Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1 | |
| Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life, as Measured by Glaucoma Related Quality of Life 15 Questionnaire | Year 1 | |
| Quality of Life, as Measured by Glaucoma Symptom Scale | Year 1 | |
| Quality of Life, as Measured by Glaucoma Utility Index |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leon Herndon, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Eye Center | Durham | North Carolina | 27705 | United States |
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Participants were recruited from the Duke Eye Center (Durham, NC, USA) and its satellite locations from December 2020 to June 2023.
| ID | Title | Description |
|---|---|---|
| FG000 | Baerveldt 350 Implant | Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant. |
| FG001 | Ahmed ClearPath 350 Implant | Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Baerveldt 350 Implant | Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant. |
| BG001 | Ahmed ClearPath 350 Implant | Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Intraocular Pressure (IOP) | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1 | eyes | eyes |
|
Up to 1 year
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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 | Baerveldt 350 Implant | Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction (heart attack) | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical failure | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Gross, MD | Duke University | 919-684-8656 | andrew.gross@duke.edu |
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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 | May 10, 2020 | Jun 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Ahmed ClearPath 350 implant | Device | The Ahmed ClearPath is a non-valved glaucoma drainage device. |
|
| Change in Humphrey Visual Field (HVF) | The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive value indicates an increase in visual field while a negative value indicates a decrease. | Baseline and Year 1 |
| Change in Thickness of the Cornea as Measured by Pachymetry | Pachymetry is an ophthalmological test that measures the thickness of the cornea. | Baseline and Year 1 |
| Change in Retinal Nerve Fiber Layer (RNFL) | The retinal nerve fiber layer (RNFL) is formed by retinal ganglion cell axons, which collect the visual impulses that begin with the rods and cones. | Baseline and Year 1 |
| Year 1 |
| Change in Self-report Dysesthesia Scale Questionnaire | Baseline and Year 1 |
| Change in Motility Exam (Hess Screen Test) | If patient is binocular | Baseline and Year 1 |
| Change in Motility Exam (Worth 4-dot) | If patient is binocular | Baseline and Year 1 |
| Change in Motility Exam (Stereo Test) | If patient is binocular | Baseline and Year 1 |
| Change in Motility Exam (9 Gaze Photos) | Baseline and Year 1 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units |
|---|
| Counts |
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| Participants |
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| eyes |
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| Primary | Number of Participants Who Experienced a Complication | Posted | Count of Participants | Participants | Up to Year 1 |
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| Secondary | Best Corrected Visual Acuity (BCVA) | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | LogMAR | Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1 | eyes | eyes |
|
|
|
| Secondary | Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking) | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | medications | Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1 |
|
|
|
| Secondary | Change in Humphrey Visual Field (HVF) | The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive value indicates an increase in visual field while a negative value indicates a decrease. | Participants with data collected at both timepoints. | Posted | Mean | Standard Deviation | dB | Baseline and Year 1 |
|
|
|
|
| Secondary | Change in Thickness of the Cornea as Measured by Pachymetry | Pachymetry is an ophthalmological test that measures the thickness of the cornea. | Participants with data collected at both timepoints. | Posted | Median | Standard Deviation | µm | Baseline and Year 1 |
|
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| Other Pre-specified | Quality of Life, as Measured by Glaucoma Related Quality of Life 15 Questionnaire | Not Posted | Year 1 | Participants |
| Other Pre-specified | Quality of Life, as Measured by Glaucoma Symptom Scale | Not Posted | Year 1 | Participants |
| Other Pre-specified | Quality of Life, as Measured by Glaucoma Utility Index | Not Posted | Year 1 | Participants |
| Other Pre-specified | Change in Self-report Dysesthesia Scale Questionnaire | Not Posted | Baseline and Year 1 | Participants |
| Other Pre-specified | Change in Motility Exam (Hess Screen Test) | If patient is binocular | Not Posted | Baseline and Year 1 | Participants |
| Other Pre-specified | Change in Motility Exam (Worth 4-dot) | If patient is binocular | Not Posted | Baseline and Year 1 | Participants |
| Other Pre-specified | Change in Motility Exam (Stereo Test) | If patient is binocular | Not Posted | Baseline and Year 1 | Participants |
| Other Pre-specified | Change in Motility Exam (9 Gaze Photos) | Not Posted | Baseline and Year 1 | Participants |
| Secondary | Change in Retinal Nerve Fiber Layer (RNFL) | The retinal nerve fiber layer (RNFL) is formed by retinal ganglion cell axons, which collect the visual impulses that begin with the rods and cones. | Participants with data collected at both timepoints. | Posted | Median | Standard Deviation | µm | Baseline and Year 1 |
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| 1 |
| 37 |
| 1 |
| 37 |
| 9 |
| 37 |
| EG001 | Ahmed ClearPath 350 Implant | Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device. | 0 | 39 | 0 | 39 | 8 | 39 |
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