Primary Open Angle Glaucoma (POAG)
Conditions
Keywords
Glaucoma, Glaucoma device, Glaucoma surgery, Intraocular pressure
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of CyPass implantation as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy
Interventions
DEVICECyPass Micro-Stent
The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye. The CyPass is implanted in the eye.
Sponsors
Transcend Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of POAG * Medicated IOP ≥ 21 and ≤ 35 mmHg * Use of 1 - 4 topical IOP lowering medications
Exclusion criteria
* Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma * Use of oral hypotensive medication treatment for glaucoma * Previous incisional glaucoma surgery, or any combined cataract-glaucoma procedure * Clinically significant ocular pathology other than POAG
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline | Baseline; Month 12 postoperative | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. Proportion of eyes is reported as a percentage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication | Month 12 postoperative | Target IOP was defined as ≥ 6 mmHg and ≤ 21 mmHg. Proportion of eyes is reported as a percentage. |
| Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline | Baseline, Month 12 postoperative | The number of unique glaucoma medications was recorded. The mean number of topical IOP-lowering medications was computed by dividing the total number of medications used (the numerator) by the total number of subjects who reported on medication use at the visit. |
Participant flow
Recruitment details
Participants were enrolled at 7 investigational sites in Germany, Bulgaria, Spain and Austria.
Pre-assignment details
This reporting group includes all treated participants.
Participants by arm
| Arm | Count |
|---|---|
| CyPass Micro-Stent Subjects received the CyPass Micro-Stent | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Investigator Decision | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Study Closed at Site | 1 |
| Overall Study | Subject Decision | 8 |
Baseline characteristics
| Characteristic | CyPass Micro-Stent |
|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 10.96 |
| Region of Enrollment Austria | 4 participants |
| Region of Enrollment Bulgaria | 8 participants |
| Region of Enrollment Germany | 33 participants |
| Region of Enrollment Spain | 3 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 36 / 50 |
| serious Total, serious adverse events | 2 / 48 | 8 / 50 |
Outcome results
Primary
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. Proportion of eyes is reported as a percentage.
Time frame: Baseline; Month 12 postoperative
Population: Eyes implanted with the CyPass 2FX device with data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CyPass Micro-Stent | Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline | 60.4 percentage of eyes |
Secondary
Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline
The number of unique glaucoma medications was recorded. The mean number of topical IOP-lowering medications was computed by dividing the total number of medications used (the numerator) by the total number of subjects who reported on medication use at the visit.
Time frame: Baseline, Month 12 postoperative
Population: Eyes implanted with the CyPass 2FX device with data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CyPass Micro-Stent | Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline | Baseline | 2.1 medications | Standard Deviation 0.99 |
| CyPass Micro-Stent | Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline | Month 12 | 1.4 medications | Standard Deviation 1.3 |
Secondary
Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication
Target IOP was defined as ≥ 6 mmHg and ≤ 21 mmHg. Proportion of eyes is reported as a percentage.
Time frame: Month 12 postoperative
Population: Eyes implanted with the CyPass 2FX device with data available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CyPass Micro-Stent | Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication | 81.4 percentage of eyes |