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Voluntary market withdrawal
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The purpose of this study is to demonstrate that the rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability using the CyPass 241-S applier, as determined at 36 months in the postmarket setting, is less than the pre-specified performance target, which is based on experience with the CyPass Model E applier in COMPASS trial TMI-09-01 (NCT01085357).
Each subject's expected participation in the study is up to 37.5 months which includes up to 42 days between the screening and surgery visits, and 36 months of post-surgery follow-up. Only one eye per subject will be implanted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CyPass System | Experimental | CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CyPass Micro-Stent implanted with CyPass 241-S applier | Device | CyPass System (Model 241-S) consists of the CyPass Micro-Stent contained in a loading device (loader) and the CyPass applier.The CyPass Micro-Stent is an implantable medical device intended for long term use. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36 | Device-related complications, as specified in the protocol, included:
| Up to Month 36 postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in IOP From Baseline at Month 36 | Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A negative change value indicates an improvement. | Baseline, Month 36 postoperative |
| Percentage of Eyes With IOP Reduction 20 Percent or More From Baseline While Using the Same or Fewer Topical Ocular Hypotensive Medications at Month 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Trial Lead, Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Phoenix | Arizona | 85016 | United States | ||
| Alcon Investigative Site |
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Of the 79 enrolled, 36 subjects were exited from the study prior to attempted implantation with the CyPass Micro-Stent. This reporting group includes all subjects with attempted implantation (43). Only one eye per subject was implanted.
Participants were enrolled at 20 investigative sites located in the United States.
Due to the CyPass voluntary global market withdrawal, enrollment was permanently suspended for this study starting 29 August 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | CyPass System | CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 22, 2017 | Aug 16, 2022 |
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| Cataract surgery | Procedure | Cataract surgery, followed by implantation of the CyPass Micro-Stent in one eye (the study eye) at the surgery visit |
|
Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. |
| Baseline, Month 36 postoperative |
| Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36 | Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). Only one eye per subject was implanted. | Month 36 postoperative |
| Percentage of Eyes With Sight-threatening Adverse Events (AEs) | Sight-threatening adverse events, as specified in the protocol, included:
| Up to Month 36 postoperative |
| Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI) | A secondary surgical intervention may have occurred for any of the following reasons:
Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE | Up to Month 36 postoperative |
| Percentage of Eyes With Ocular SSIs Associated With CyPass Placement and Stability | A secondary surgical intervention may have occurred for either of the following reasons:
Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE | Up to Month 36 postoperative |
| Orange |
| California |
| 92868 |
| United States |
| Alcon Investigative Site | Fort Collins | Colorado | 80528 | United States |
| Alcon Investigative Site | Jacksonville | Florida | 32256 | United States |
| Alcon Investigative Site | Panama City | Florida | 32405 | United States |
| Alcon Investigative Site | Gainesville | Georgia | 30501 | United States |
| Alcon Investigative Site | Marietta | Georgia | 30060 | United States |
| Alcon Investigative Site | Garden City | Kansas | 67846 | United States |
| Alcon Investigative Site | Fraser | Michigan | 48026 | United States |
| Alcon Investigative Site | St Louis | Missouri | 63131 | United States |
| Alcon Investivative Site | St Louis | Missouri | 63141 | United States |
| Alcon Investigative Site | Vineland | New Jersey | 08361 | United States |
| Alcon Investigative Site | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Alcon Investigative Site | Chambersburg | Pennsylvania | 17201 | United States |
| Alcon Investigative Site | Austin | Texas | 78731 | United States |
| Alcon Investigative Site | El Paso | Texas | 79902 | United States |
| Alcon Investigative Site | Houston | Texas | 77030 | United States |
| Alcon Investigative Site | Bellevue | Washington | 98004-3012 | United States |
| Alcon Investigative Site | Kenosha | Wisconsin | 53142 | United States |
| Alcon Investigative Site | Racine | Wisconsin | 53405 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Intent to Treat Analysis Set: All study eyes for which a CyPass Micro-Stent implant was attempted
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| ID | Title | Description |
|---|---|---|
| BG000 | CyPass System | CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Region of Enrollment | Number | 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 | Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36 | Device-related complications, as specified in the protocol, included:
| Intent-to-Treat (ITT) Analysis Set | Posted | Number | percentage of eyes | Up to Month 36 postoperative | eyes | eyes |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in IOP From Baseline at Month 36 | Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A negative change value indicates an improvement. | ITT Analysis Set with data at visit | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 36 postoperative | eyes | eyes |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Eyes With IOP Reduction 20 Percent or More From Baseline While Using the Same or Fewer Topical Ocular Hypotensive Medications at Month 36 | Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. | ITT Analysis Set with data at visit | Posted | Number | 95% Confidence Interval | percentage of eyes | Baseline, Month 36 postoperative | eyes | eyes |
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| Secondary | Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36 | Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). Only one eye per subject was implanted. | ITT Analysis Set with data at visit | Posted | Number | 95% Confidence Interval | percentage of eyes | Month 36 postoperative | eyes | eyes |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Eyes With Sight-threatening Adverse Events (AEs) | Sight-threatening adverse events, as specified in the protocol, included:
| ITT Analysis Set | Posted | Number | 95% Confidence Interval | percentage of eyes | Up to Month 36 postoperative | eyes | eyes |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI) | A secondary surgical intervention may have occurred for any of the following reasons:
Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE | ITT Analysis Set | Posted | Number | 95% Confidence Interval | percentage of eyes | Up to Month 36 postoperative | eyes | eyes |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Eyes With Ocular SSIs Associated With CyPass Placement and Stability | A secondary surgical intervention may have occurred for either of the following reasons:
Note: If an eye had multiple occurrences of an AE, the eye is presented only once in the respective eye count column (n) for the corresponding AE | ITT Analysis Set | Posted | Number | 95% Confidence Interval | percentage of eyes | Up to Month 36 postoperative | eyes | eyes |
|
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Adverse events (AEs) were collected pre-treatment (Day -42 to Day -1) up to Month 36 Follow-up/Exit (Day +1050 to Day 1140). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
This analysis population includes all study eyes for which a CyPass Micro-Stent implant was attempted (Intent to Treat Analysis Set). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
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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 | Pretreatment | Events reported in this group occurred prior to attempted implantation with the test article | 0 | 43 | 0 | 43 | 3 | 43 |
| EG001 | CyPass Study Eye | Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye | 0 | 43 | 4 | 43 | 13 | 43 |
| EG002 | CyPass Systemic | Events reported in this group occurred after attempted implantation with the test article and include systemic adverse events plus ocular events in the non-study eye | 1 | 43 | 7 | 43 | 21 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Paracentesis eye | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Throat cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Visual field defect | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Glaucoma drainage device placement | Surgical and medical procedures | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Posterior capsule opacification | Eye disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Visual field defect | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA (23.0) | Systematic Assessment |
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Considering the achieved sample size in this study (less than 10% of intended), no definitive conclusion can be made with respect to the rate of CyPass-related complications.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CDMA Clinical Lead, Surgical | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2017 | Aug 16, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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