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The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100R/L in subjects previously enrolled in Glaukos Study GC-003.
The goal of this study was to demonstrate that use of this device in conjunction with cataract surgery did not result in a rate of sight-threatening adverse events, after 5 years of implantation that was higher than the rate of sight-threatening adverse events that occurred after cataract surgery alone, by more than a non-inferiority margin of 5%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized iStent | Implantation of one iStent in conjunction with cataract surgery, patients randomized to group | ||
| Randomized cataract surgery | Cataract surgery alone, patients randomized to group | ||
| Non-randomized iStent | Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Sight-threatening Adverse Events | The primary endpoint is the occurrence of sight-threatening adverse events. The rate of sight-threatening adverse events at each visit will be calculated for the three treatment groups (randomized control group, randomized iStent group, and non-randomized iStent group) separately. The summary will also be performed for pooling the randomized iStent and non-randomized iStent group. | 80 Month average |
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Inclusion Criteria:
Exclusion Criteria:
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Extended follow-up of subjects previously enrolled in Glaukos Study GC-003
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Wells, PharmD, MBA | Glaukos Corporation | Study Director |
| Jay Katz, MD | Wills Eye Institute; Thomas Jefferson University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills | California | 90210 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized iStent | Implantation of one iStent in conjunction with cataract surgery, patients randomized to group |
| FG001 | Randomized Cataract Surgery | Cataract surgery alone, patients randomized to group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Petaluma |
| California |
| 94954 |
| United States |
| Sacramento | California | 95817 | United States |
| San Clemente | California | 92673 | United States |
| Santa Maria | California | 93454 | United States |
| Parker | Colorado | 80134 | United States |
| Boynton Beach | Florida | 33426 | United States |
| Miami | Florida | 33176 | United States |
| Tampa | Florida | 33603 | United States |
| Morrow | Georgia | 30260 | United States |
| Indianapolis | Indiana | 46260 | United States |
| Overland Park | Kansas | 66213 | United States |
| Louisville | Kentucky | 40206 | United States |
| Baton Rouge | Louisiana | 70806 | United States |
| Saint Joseph | Michigan | 49085 | United States |
| Bloomington | Minnesota | 55431 | United States |
| Edina | Minnesota | 55435 | United States |
| Independence | Missouri | 64055 | United States |
| Kansas City | Missouri | 64133 | United States |
| Las Vegas | Nevada | 89121 | United States |
| Winston-Salem | North Carolina | 27101 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Brookville | Pennsylvania | 15825 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Pittsburgh | Pennsylvania | 15122 | United States |
| Beaumont | Texas | 77702 | United States |
| FG002 | Non-randomized iStent | Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group |
| COMPLETED |
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| NOT COMPLETED |
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Note: 108 of the subjects in the original pivotal trial participated in the follow-up study. There were 51 subjects from the randomized stent group, 35 from the cataract only group, and 22 from the non-randomized stent group who participated in this study
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized iStent | Implantation of one iStent in conjunction with cataract surgery, patients randomized to group |
| BG001 | Randomized Cataract Surgery | Cataract surgery alone, patients randomized to group |
| BG002 | Non-randomized iStent | Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group |
| BG003 | Total | Total of all reporting groups |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Rate of Sight-threatening Adverse Events | The primary endpoint is the occurrence of sight-threatening adverse events. The rate of sight-threatening adverse events at each visit will be calculated for the three treatment groups (randomized control group, randomized iStent group, and non-randomized iStent group) separately. The summary will also be performed for pooling the randomized iStent and non-randomized iStent group. | Posted | Number | percentage of subjects | 80 Month average |
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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 | Randomized iStent | Implantation of one iStent in conjunction with cataract surgery, patients randomized to group | 0 | 111 | 13 | 111 | ||
| EG001 | Randomized Cataract Surgery | Cataract surgery alone, patients randomized to group | 0 | 122 | 15 | 122 | ||
| EG002 | Non-randomized iStent | Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group | 0 | 46 | 6 | 46 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Age-related macular degeneration or worsening of AMD | Eye disorders | Systematic Assessment |
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| Epiretinal membrane | Eye disorders | Systematic Assessment |
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| Loss of BCVA greater or equal to 3 lines | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Wells, PharmD, MBA, RAC | Glaukos | 949-367-9600 | 227 | jwells@glaukos.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Male |
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