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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CyPass Micro-Stent | Experimental | Subjects receive the CyPass Micro-Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CyPass Micro-Stent | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; Month 12 postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 12 postoperative |
| Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vice President of Medical Affairs | Transcend Medical, Inc. | Study Chair |
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This reporting group includes all treated participants.
Participants were enrolled at 7 investigational sites in Germany, Bulgaria, Spain and Austria.
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| ID | Title | Description |
|---|---|---|
| FG000 | CyPass Micro-Stent | Subjects received the CyPass Micro-Stent |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CyPass Micro-Stent | Subjects received the CyPass Micro-Stent |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Eyes implanted with the CyPass 2FX device with data available. | Posted | Number | percentage of eyes | Baseline; Month 12 postoperative | eyes | eyes |
|
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury or any untoward clinical sign occurring in a study subject, whether or not related to the CyPass device. AEs were collected from time of consent to study exit (Month 24 postoperative).
Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.
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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 | Non-Ocular Adverse Events | At risk population for non-ocular adverse events is included with unit of subjects |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Secondary surgical intervention | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyphema | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Medical Affairs | Transcend Medical, Inc. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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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. |
| Baseline, Month 12 postoperative |
| Lost to Follow-up |
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| Study Closed at Site |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| eyes |
|
|
| 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. | Eyes implanted with the CyPass 2FX device with data available. | Posted | Number | percentage of eyes | Month 12 postoperative | eyes | 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. | Eyes implanted with the CyPass 2FX device with data available. | Posted | Mean | Standard Deviation | medications | Baseline, Month 12 postoperative | eyes | eyes |
|
|
|
| 2 |
| 48 |
| 0 |
| 48 |
| EG001 | Ocular Adverse Events | At risk population for ocular adverse events is included with unit of eyes. | 8 | 50 | 36 | 50 |
| IOP above target | Investigations | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| BCVA loss ≥ 2 lines at/after 3 months postoperatively | Eye disorders | Systematic Assessment |
|
| Secondary surgical intervention: IOP management | Injury, poisoning and procedural complications | Systematic Assessment |
|
| IOP ≥ 10 mmHg over baseline or > 30 mmHg at/after 1 month postoperatively | Investigations | Systematic Assessment |
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| CyPass device obstruction | Investigations | Systematic Assessment |
|
| Secondary surgical intervention: Cataract removal | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Secondary surgical intervention: CyPass obstruction lysis | Injury, poisoning and procedural complications | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.