Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate open angle glaucoma.
The objective of this trial is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 (hereinafter referred to as GTS400) in combination with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma. This is a prospective, randomized, concurrently controlled, parallel groups, multicenter clinical investigation of the GTS400. Treatment will consist of either implantation of GTS400 stents in the study eye in conjunction with cataract surgery (Group 1, Investigational Group), or cataract surgery only (Group 2, Control Group). Clinical data through 12 months postoperative will form the basis of a pre-market approval (PMA) submission. Subjects will be followed for two years postoperatively.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery |
|
| 2 | Placebo Comparator | Control Group (Group 2): Cataract surgery only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glaucoma Stent Surgery (GTS400 Stent) | Device | ab interno trabecular bypass stent surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications | Percent reaching this endpoint | 12 months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Ocular Hypotensive Medications by Visit | 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not meeting inclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Head of Clinical Affairs | Glaukos Corporation | Study Director |
Not provided
62 enrolled and 44 randomized. Therefore 18 subjects enrolled who either did not pass baseline visit or were not randomized to the trial.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 1 Treatment Group: iStent + Cataract Surgery | Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery |
| FG001 | 2 Control Group: Cataract Surgery Only | Control Group (Group 2): Cataract surgery only |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1 Treatment Group: iStent + Cataract Surgery | Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery |
| BG001 | 2 Control Group: Cataract Surgery Only |
| 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 |
| 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 | Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications | Percent reaching this endpoint | Number of subjects at Month 12 with IOP ≤ 18 mmHg without topical hypotensive medications | Posted | Number | participants | 12 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Treatment Group: iStent + Cataract Surgery | Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IOP increase >=10 mmHg versus baseline IOP at any visit | Eye disorders | Adverse Event Term |
There are no limitations and caveats to report
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Wells. Sr VP, Clinical, Regulatory, and Quality Affairs | Glaukos | 949-367-9600 | 227 | jwells@glaukos.com |
Not provided
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| cataract surgery alone | Procedure | Cataract surgery alone |
|
|
Control Group (Group 2): Cataract surgery only
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Other Pre-specified | Number of Ocular Hypotensive Medications by Visit | Posted | Mean | Standard Deviation | medications | 12 months |
|
|
|
| 0 |
| 27 |
| 15 |
| 27 |
| EG001 | 2 Control Group: Cataract Surgery Only | Control Group (Group 2): Cataract surgery only | 0 | 17 | 12 | 17 |
| Posterior Capsule Opacification | Eye disorders | Adverse Event Term |
|
| Corneal Abrasion | Eye disorders | Adverse Event Term |
|
| Conjunctivitis | Eye disorders | Adverse Event Term |
|
| Iritis | Eye disorders | Adverse Event Term |
|
| Punctate Corneal Staining | Eye disorders | Adverse Event Term |
|
| Superficial Punctate Keratitis | Eye disorders | Adverse Event Term |
|
| BCVA Loss greater than or equal to 1 line after 3 months post-op | Eye disorders | Adverse event term |
|
| Eye pain | Eye disorders | Adverse Event Term |
|
| Blurry Vision | Eye disorders | Adverse Event Term |
|
| Retinal Detachment | Eye disorders | Adverse Event Term |
|
Not provided
Not provided