Open-Angle Glaucoma
Conditions
Keywords
Open angle, Glaucoma, Cataract, Surgery
Brief summary
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.
Detailed description
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.
Interventions
DEVICEiStent plus Cataract Surgery
ab interno trabecular bypass stent surgery
PROCEDURECataract surgery only
Cataract surgery only
Sponsors
Glaukos Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
IOP measurement
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with open-angle glaucoma (OAG) in the study eye. Pseudoexfoliative and pigmentary glaucoma are also acceptable diagnoses. * Subject on at least one glaucoma medication * Able and willing to attend follow up visits for two years post operative * Able and willing to sign informed consent
Exclusion criteria
* Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc) * Angle closure glaucoma * Fellow eye already enrolled
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds | 12 months | Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 12 months | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Following screening, eligible subjects underwent a wash out of topical hypotensive medication prior to the baseline exam.
Participants by arm
| Arm | Count |
|---|---|
| A--iStent Plus Cataract Surgery iStent plus Cataract Surgery | 116 |
| B--Cataract Surgery Only Cataract Surgery only | 123 |
| Total | 239 |
Baseline characteristics
| Characteristic | B--Cataract Surgery Only | A--iStent Plus Cataract Surgery | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 104 Participants | 97 Participants | 201 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 19 Participants | 38 Participants |
| Age, Continuous | 72.88 years STANDARD_DEVIATION 8.66 | 73.96 years STANDARD_DEVIATION 7.66 | 73.42 years STANDARD_DEVIATION 8.11 |
| Region of Enrollment United States | 123 participants | 116 participants | 239 participants |
| Sex: Female, Male Female | 71 Participants | 70 Participants | 141 Participants |
| Sex: Female, Male Male | 52 Participants | 46 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 27 / 116 | 42 / 123 |
| serious Total, serious adverse events | 1 / 116 | 1 / 123 |
Outcome results
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
Time frame: 12 months
Population: Intent to treat analysis of all enrolled subjects using non-responder approach
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A--iStent Plus Cataract Surgery | Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds | 68 percent of subjects achieving endpoint |
| B--Cataract Surgery Only | Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds | 50 percent of subjects achieving endpoint |
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
Time frame: 12 months
Population: Intent to treat population using non-responder approach
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A--iStent Plus Cataract Surgery | Efficacy | 64 percent |
| B--Cataract Surgery Only | Efficacy | 47 percent |