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This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients.
This is a prospective, multicenter, single-masked, randomized clinical trial comparing the Hydrus Microstent to two iStent implants for the reduction of intraocular pressure in phakic patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma. Post-operative follow-up visits will be conducted at regular intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrus Microstent | Experimental | Patients randomized to the Hydrus Microstent . |
|
| iStent Trabecular Micro Bypass | Active Comparator | Patients randomized to the iStent Trabecular Micro Bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrus Microstent | Device | Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unmedicated IOP </= 19 mmHg at 12 Months | Percentage of subjects with IOP \ | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months | The percentage of subjects who are not using ocular hypotensive medications at 12 and 24 months | 12 & 24 Months |
| Mean Medication Use at 12 and 24 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julian Garcia Feijoo, Prof. Med. | Madrid, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Richard Hope at Ivantis | Irvine | California | 92618 | United States |
152 patients were randomized
Patients were screened and enrolled at 12 investigational sites located outside of the United States
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydrus Microstent | Subjects underwent 1 Hydrus implantation |
| FG001 | iStent Trabecular Micro Bypass | Subjects underwent 2 iStents implantation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Intent-to-Treat (ITT) - All participants randomized and grouped according to their randomization assignment
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydrus Microstent | Subjects underwent 1 Hydrus implantation |
| BG001 | iStent Trabecular Micro Bypass | Subjects underwent 2 iStents implantation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Unmedicated IOP </= 19 mmHg at 12 Months | Percentage of subjects with IOP \ | Intent-to-Treat (ITT) | Posted | Number | percentage of participants | 12 months |
|
24 Months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
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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 | Hydrus Microstent | Subjects underwent 1 Hydrus implantation | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BCVA loss >/= 2 lines ETDRS >/= 3 months | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BCVA loss >= 2 lines ETDRS >= 3M (Post-Operative) | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Hope | Ivantis, Inc. | 949-333-1310 | rhope@ivantisinc.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 | Mar 7, 2012 | Nov 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| iStent Trabecular Micro Bypass | Device | Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber. |
|
The mean medication use at 12 and 24 months
| 12 & 24 Months |
| Unmedicated IOP </= 19 mmHg at 24 Months | Percentage of subjects with IOP \ | 24 Months |
| Unmedicated IOP </= 18 mmHg at 12 Months | Percentage of subjects with IOP \ | 12 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months | The percentage of subjects who are not using ocular hypotensive medications at 12 and 24 months | Intent-to-Treat (ITT). Number of Participants Analyzed at 24 Months in the Hydrus Microstent arm are different than at 12 Months due to patients lost to follow-up | Posted | Number | percentage of participants | 12 & 24 Months |
|
|
|
| Secondary | Mean Medication Use at 12 and 24 Months | The mean medication use at 12 and 24 months | Intent-to-Treat (ITT). Number of Participants Analyzed at 24 Months in the Hydrus Microstent arm are different than at 12 Months due to patients lost to follow-up | Posted | Mean | Standard Deviation | number of medications | 12 & 24 Months |
|
|
|
| Secondary | Unmedicated IOP </= 19 mmHg at 24 Months | Percentage of subjects with IOP \ | Intent-to-Treat (ITT). Number of Participants Analyzed at 24Months in the Hydrus Microstent arm are different than at 12 Months due to patients lost to follow-up | Posted | Number | percentage of participants | 24 Months |
|
|
|
| Secondary | Unmedicated IOP </= 18 mmHg at 12 Months | Percentage of subjects with IOP \ | Intent-to-Treat (ITT) | Posted | Number | percentage of participants | 12 months |
|
|
|
| 75 |
| 7 |
| 75 |
| 24 |
| 75 |
| EG001 | iStent Trabecular Micro Bypass | Subjects underwent 2 iStents implantation | 1 | 77 | 14 | 77 | 23 | 77 |
| Cataract | Eye disorders | Systematic Assessment |
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| IOP Increase | Eye disorders | Systematic Assessment |
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| IOP increase (>=10 mmHg than BL >= 1M) | Eye disorders | Systematic Assessment |
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| Inflammation lasting >1M | Eye disorders | Systematic Assessment |
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| Proliferative Diabetic Retinopathy | Eye disorders | Systematic Assessment |
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| Uncontrolled Glaucoma | Eye disorders | Systematic Assessment |
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| Wet Age Related Macular Degeneration | Eye disorders | Systematic Assessment |
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| Device Obstruction (Post-Operative) | Eye disorders | Systematic Assessment |
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| PAS with Device Obstruction (Post-Operative) | Eye disorders | Systematic Assessment |
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| PAS without Device Obstruction (Post-Operative) | Eye disorders | Systematic Assessment |
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| Device Malposition (Intraoperative) | Eye disorders | Systematic Assessment |
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"If the Clinical Investigation is multi-centered, any publication based on the results obtained at the Investigation Site (or a group of sites) shall not be made before the first multi-center publication."
| 24 Months |
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| 24 Months |
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