Open-angle Glaucoma
Conditions
Keywords
Open angle, Glaucoma, Cataract, Surgery
Brief summary
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.
Detailed description
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.
Interventions
DEVICEGlaucoma Stent Surgery (GTS400 Stent)
ab interno trabecular bypass stent surgery
PROCEDUREcataract surgery alone
Cataract surgery alone
Sponsors
Glaukos Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mild to moderate Open-Angle Glaucoma with specific criteria, in need of cataract surgery * Subject willing to attend scheduled follow-up exams for two years postoperatively, Subject willing to provide written informed consent on the Institutional Review Board approved Informed Consent Form
Exclusion criteria
Not meeting inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications | 12 months | Percent reaching this endpoint |
Other
| Measure | Time frame |
|---|---|
| Number of Ocular Hypotensive Medications by Visit | 12 months |
Participant flow
Pre-assignment details
62 enrolled and 44 randomized. Therefore 18 subjects enrolled who either did not pass baseline visit or were not randomized to the trial.
Participants by arm
| Arm | Count |
|---|---|
| 1 Treatment Group: iStent + Cataract Surgery Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery | 27 |
| 2 Control Group: Cataract Surgery Only Control Group (Group 2): Cataract surgery only | 17 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | 1 Treatment Group: iStent + Cataract Surgery | 2 Control Group: Cataract Surgery Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 26 Participants | 14 Participants | 40 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 4 Participants |
| Region of Enrollment United States | 27 participants | 17 participants | 44 participants |
| Sex: Female, Male Female | 20 Participants | 10 Participants | 30 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 27 | 12 / 17 |
| serious Total, serious adverse events | 0 / 27 | 0 / 17 |
Outcome results
Primary
Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications
Percent reaching this endpoint
Time frame: 12 months
Population: Number of subjects at Month 12 with IOP ≤ 18 mmHg without topical hypotensive medications
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 Treatment Group: iStent + Cataract Surgery | Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications | 18 participants |
| 2 Control Group: Cataract Surgery Only | Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications | 4 participants |
Other Pre-specified
Number of Ocular Hypotensive Medications by Visit
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Treatment Group: iStent + Cataract Surgery | Number of Ocular Hypotensive Medications by Visit | 0.4 medications | Standard Deviation 0.8 |
| 2 Control Group: Cataract Surgery Only | Number of Ocular Hypotensive Medications by Visit | 0.9 medications | Standard Deviation 0.7 |