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| Name | Class |
|---|---|
| New World Medical, Inc. | INDUSTRY |
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The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma.
The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma. Participation will last for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silicone Plate Ahmed Glaucoma Valve | Active Comparator | Silicone plate Ahmed Glaucoma Valve |
|
| Porous Plate Ahmed Glaucoma Valve | Experimental | Porous Plate Ahmed Glaucoma Valve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silicone plate Ahmed Glaucoma Valve (Model FP7) | Device | This intervention is conducted as a surgical intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraocular Pressure | The primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-Glaucoma Medications | The mean number of anti-glaucoma medications in the porous plate group as compared to the silicone plate group at 12 months. | 12 months |
| Surgical Success | Surgical success in the porous plate group as compared to the silicone plate group at 12 months. Surgical success was defined as intraocular pressure of ≤5 mmHg or ≥21 mmHg (with or without glaucoma medications), with no loss of light perception, and no additional glaucoma procedures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter A Netland, MD, PhD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32765127 | Result | Roa TM, Netland PA, Costa VP, Sarkisian SR Jr, Al-Aswad LA, Moster MR, Ahmed IIK. Comparison of Silicone- and Porous-Plate Ahmed Glaucoma Valves. Med Devices (Auckl). 2020 Jul 16;13:213-221. doi: 10.2147/MDER.S258498. eCollection 2020. |
| Label | URL |
|---|---|
| Study results indexed on Pub Med | View source |
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Described in study results - https://pubmed.ncbi.nlm.nih.gov/32765127/
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| ID | Title | Description |
|---|---|---|
| FG000 | Silicone Plate Ahmed Glaucoma Valve | Silicone plate Ahmed Glaucoma Valve Silicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention. |
| FG001 | Porous Plate Ahmed Glaucoma Valve | Porous Plate Ahmed Glaucoma Valve Porous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Silicone Plate Ahmed Glaucoma Valve | Silicone plate Ahmed Glaucoma Valve Silicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention. |
| BG001 | Porous Plate Ahmed Glaucoma Valve |
| 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 | Change in Intraocular Pressure | The primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group. | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
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 | Silicone Plate Ahmed Glaucoma Valve | Silicone plate Ahmed Glaucoma Valve Silicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertensive phase | Eye disorders | Non-systematic Assessment | Hypertensive phase was defined as intraocular pressure more than 21 mmHg during the first three months postoperatively. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter A. Netland, MD, PhD | University of Virginia | 4349821086 | pan9c@virginia.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 | Mar 25, 2015 | Aug 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| D015355 | Glaucoma, Neovascular |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Porous Plate Ahmed Glaucoma Valve (Model M4) | Device | This intervention is conducted as a surgical intervention. |
|
| 12 months |
Porous Plate Ahmed Glaucoma Valve
Porous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Pre-operative intraocular pressure | Mean | Standard Deviation | mmHg |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Anti-Glaucoma Medications | The mean number of anti-glaucoma medications in the porous plate group as compared to the silicone plate group at 12 months. | Posted | Mean | Standard Deviation | glaucoma medications | 12 months |
|
|
|
| Secondary | Surgical Success | Surgical success in the porous plate group as compared to the silicone plate group at 12 months. Surgical success was defined as intraocular pressure of ≤5 mmHg or ≥21 mmHg (with or without glaucoma medications), with no loss of light perception, and no additional glaucoma procedures. | Posted | Number | surgical success | 12 months |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 13 |
| 26 |
| EG001 | Porous Plate Ahmed Glaucoma Valve | Porous Plate Ahmed Glaucoma Valve Porous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention. | 0 | 26 | 0 | 26 | 15 | 26 |
|
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