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The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.
The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract. Pre-operative unmedicated baseline pressures will be compared with post operative values in both study arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A--iStent plus Cataract Surgery | Active Comparator | iStent plus Cataract Surgery |
|
| B--Cataract Surgery Only | Active Comparator | Cataract Surgery only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iStent plus Cataract Surgery | Device | ab interno trabecular bypass stent surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds | Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Subjects with an intraocular pressure (IOP) reduction from baseline of greater than or equal to 20% without use of topical hypotensive medication at 12 months | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Wells, PharmD, MBA | Glaukos Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assil Eye Institute | Beverly Hills | California | 90210 | United States | ||
| North Bay Eye Associates Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20828829 | Result | Samuelson TW, Katz LJ, Wells JM, Duh YJ, Giamporcaro JE; US iStent Study Group. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011 Mar;118(3):459-67. doi: 10.1016/j.ophtha.2010.07.007. Epub 2010 Sep 15. | |
| 22814041 | Result |
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Following screening, eligible subjects underwent a wash out of topical hypotensive medication prior to the baseline exam.
The study recruited subjects between April 2005 and February 2008. The main part of the study consisted of a randomized portion where subjects were randomized 1:1 to either iStent plus Cataract Surgery, or Cataract Surgery only. Following the randomized portion, addtional subjects were enrolled in a non-randomized portion.
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| ID | Title | Description |
|---|---|---|
| FG000 | A--iStent Plus Cataract Surgery | iStent plus Cataract Surgery |
| FG001 | B--Cataract Surgery Only | Cataract Surgery only |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 12 Months Follow-up |
|
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IOP measurement
| Cataract surgery only | Procedure | Cataract surgery only |
|
|
| Petaluma |
| California |
| 94954 |
| United States |
| Ellison Ambulatory Care Center | Sacramento | California | 95817 | United States |
| Harvard Eye Associates | San Clemente | California | 92673 | United States |
| Shepard Eye Center | Santa Maria | California | 93454 | United States |
| Glaucoma Consultants of Colorado | Littleton | Colorado | 80120 | United States |
| Florida Eye Microsurgical Institute, Inc. | Boynton Beach | Florida | 33426 | United States |
| The Center for Excellence in Eye Care | Miami | Florida | 33176 | United States |
| International Eye Center | Tampa | Florida | 33603 | United States |
| Clayton Eye Center | Morrow | Georgia | 30260 | United States |
| Indiana University | Indianapolis | Indiana | 46260 | United States |
| Stiles Eyecare Excellence | Overland Park | Kansas | 66213 | United States |
| The Eye Care Institute Building | Louisville | Kentucky | 40206 | United States |
| Williamson Nelson Eye Center | Baton Rouge | Louisiana | 70806 | United States |
| Kresge Eye Institute | Detroit | Michigan | 48201 | United States |
| Great Lakes Eye Care | Saint Joseph | Michigan | 49085 | United States |
| Chu Vision Institute | Edina | Minnesota | 55435 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55404 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Discover Vision Centers | Independence | Missouri | 64055 | United States |
| Silverstein Eye Centers | Kansas City | Missouri | 64133 | United States |
| The Shepherd Eye Center | Las Vegas | Nevada | 89121 | United States |
| Glaucoma Consultants of Capital Region | Slingerlands | New York | 12159 | United States |
| Donald J. Digby and Associates | Greensboro | North Carolina | 27408 | United States |
| James Branch MD | Winston-Salem | North Carolina | 27101 | United States |
| Cinicinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Laurel Eye Center | Brookville | Pennsylvania | 15825 | United States |
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Associates in Ophthalmology | Pittsburgh | Pennsylvania | 15122 | United States |
| UPMC Eye Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Southeast Texas Medical Association, L.L.P. | Beaumont | Texas | 77702 | United States |
| Craven ER, Katz LJ, Wells JM, Giamporcaro JE; iStent Study Group. Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-up. J Cataract Refract Surg. 2012 Aug;38(8):1339-45. doi: 10.1016/j.jcrs.2012.03.025. |
| COMPLETED |
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| NOT COMPLETED |
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| 24 Months Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A--iStent Plus Cataract Surgery | iStent plus Cataract Surgery |
| BG001 | B--Cataract Surgery Only | Cataract Surgery only |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| 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 | Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds | Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months | Intent to treat analysis of all enrolled subjects using non-responder approach | Posted | Number | 95% Confidence Interval | percent of subjects achieving endpoint | 12 months |
|
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| ||||||||||||||||||||||||||||
| Secondary | Efficacy | Subjects with an intraocular pressure (IOP) reduction from baseline of greater than or equal to 20% without use of topical hypotensive medication at 12 months | Intent to treat population using non-responder approach | Posted | Number | 95% Confidence Interval | percent | 12 months |
|
|
Two years
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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 | A--iStent Plus Cataract Surgery | iStent plus Cataract Surgery | 1 | 116 | 27 | 116 | ||
| EG001 | B--Cataract Surgery Only | Cataract Surgery only | 1 | 123 | 42 | 123 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Best Corrected Visual Acuity loss greater than 1 line at or after the 3 month visit | Eye disorders | Standard terminology | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Early post-op corneal edema | Eye disorders | Standard terminology | Systematic Assessment |
| |
| Posterior capsular opacification | Eye disorders | Standard terminology | Non-systematic Assessment |
| |
| Any BCVA loss greater than 1 line of vision at or after the 3 month visit | Eye disorders | Standard terminology | Systematic Assessment |
| |
| Blurry vision or visual disturbance | Eye disorders | Standard terminology | Systematic Assessment |
|
Open label given no way to mask treatment group to surgeon and visibility of iStent device upon gonioscopy.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Wells, Sr. VP, Clinical, Regulatory, and Quality Affairs | Glaukos | 949-367-9600 | 227 | jwells@glaukos.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D018918 | Phacoemulsification |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D059708 | Ultrasonic Surgical Procedures |
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| >=65 years |
|
| Male |
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