Cataract, Primary Open-angle Glaucoma
Conditions
Keywords
CyPass Micro-Stent
Brief summary
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).
Detailed description
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.
Interventions
DEVICECyPass Micro-Stent implanted with CyPass 241-S applier
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.
PROCEDURECataract surgery
Cataract surgery, followed by implantation of the CyPass Micro-Stent in one eye (the study eye) at the surgery visit
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits * Diagnosis of primary open angle glaucoma (POAG) * Medicated intraocular pressure (IOP) of ≥10 millimeters mercury (mmHg) and ≤25 mmHg, or an unmedicated IOP of ≥21 mmHg and ≤33 mmHg * An operable age-related cataract eligible for phacoemulsification * Visual acuity as specified in the protocol * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Inability to complete a visual field test prior to surgery * Use of ocular hypotensive medication/s, as specified in the protocol * Diagnosis of glaucoma other than POAG, as specified in the protocol * Other medical conditions, as specified in the protocol * Proliferative diabetic retinopathy * Previous surgery for retinal detachment * Previous corneal surgery * Wet age-related macular degeneration * Poor vision in the non-study eye not due to cataract * Significant ocular inflammation or infection within 30 days of screening visit * Uncontrolled systemic diseases that may put the subject's health at risk and/or prevent the subject from completing all study visits * Women who are pregnant or nursing * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36 | Up to Month 36 postoperative | Device-related complications, as specified in the protocol, included: * Failure to implant CyPass, defined as inability to successfully deploy or insert the CyPass. * Clinically significant CyPass malposition, defined as CyPass positioning after deployment such that: * The device is not in the supraciliary space, or * Clinical sequela resulting from device position including, but not limited to: * Secondary surgical intervention to modify device position (eg, repositioning, proximal end trimming or explantation) * Corneal endothelial touch by device * Corneal edema leading to loss of BCDVA \> 2 lines at the last postoperative visit, in comparison with preoperative BCDVA * Progressive ECL, defined as ongoing reduction in endothelial cell count of 30% or more relative to the screening ECD value, where 'ongoing reduction in endothelial cell count' is defined as losses continuing after Visit 5 (6 Month Follow-up). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Month 36 postoperative | Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. |
| Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36 | Month 36 postoperative | Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). Only one eye per subject was implanted. |
| Mean Change in IOP From Baseline at Month 36 | Baseline, Month 36 postoperative | Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A negative change value indicates an improvement. |
| Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI) | Up to Month 36 postoperative | A secondary surgical intervention may have occurred for any of the following reasons: * CyPass device explantation associated with CyPass placement and stability * CyPass device explantation NOT associated with CyPass placement and stability * Unplanned ocular surgical reintervention associated with CyPass placement and stability * Unplanned ocular surgical reintervention NOT associated with CyPass placement and stability (as defined in the protocol). 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 |
| Percentage of Eyes With Ocular SSIs Associated With CyPass Placement and Stability | Up to Month 36 postoperative | A secondary surgical intervention may have occurred for either of the following reasons: * CyPass device explantation associated with CyPass placement and stability * Unplanned ocular surgical reintervention associated with CyPass placement and stability. 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 |
| Percentage of Eyes With Sight-threatening Adverse Events (AEs) | Up to Month 36 postoperative | Sight-threatening adverse events, as specified in the protocol, included: * Persistent Best Corrected Distance Visual Acuity (BCDVA) loss of 3 lines or more * Endophthalmitis * Corneal decompensation * Retinal detachment * Severe choroidal hemorrhage or detachment * Aqueous misdirection. 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| CyPass System CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | COVID 19 | 2 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | CyPass System |
|---|---|
| Age, Continuous | 71.4 years STANDARD_DEVIATION 5.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Region of Enrollment United States | 43 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 43 | 1 / 43 |
| other Total, other adverse events | 3 / 43 | 13 / 43 | 21 / 43 |
| serious Total, serious adverse events | 0 / 43 | 4 / 43 | 7 / 43 |
Outcome results
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: * Failure to implant CyPass, defined as inability to successfully deploy or insert the CyPass. * Clinically significant CyPass malposition, defined as CyPass positioning after deployment such that: * The device is not in the supraciliary space, or * Clinical sequela resulting from device position including, but not limited to: * Secondary surgical intervention to modify device position (eg, repositioning, proximal end trimming or explantation) * Corneal endothelial touch by device * Corneal edema leading to loss of BCDVA \> 2 lines at the last postoperative visit, in comparison with preoperative BCDVA * Progressive ECL, defined as ongoing reduction in endothelial cell count of 30% or more relative to the screening ECD value, where 'ongoing reduction in endothelial cell count' is defined as losses continuing after Visit 5 (6 Month Follow-up).
Time frame: Up to Month 36 postoperative
Population: Intent-to-Treat (ITT) Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CyPass System | Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36 | 2.3 percentage of eyes |
p-value: 0.187Exact one-sided binomial test
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.
Time frame: Baseline, Month 36 postoperative
Population: ITT Analysis Set with data at visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CyPass System | Mean Change in IOP From Baseline at Month 36 | -3.71 mmHg | Standard Deviation 4.881 |
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.
Time frame: Month 36 postoperative
Population: ITT Analysis Set with data at visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CyPass System | Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36 | 61.8 percentage of 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.
Time frame: Baseline, Month 36 postoperative
Population: ITT Analysis Set with data at visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CyPass System | 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 | 41.2 percentage of eyes |
Secondary
Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI)
A secondary surgical intervention may have occurred for any of the following reasons: * CyPass device explantation associated with CyPass placement and stability * CyPass device explantation NOT associated with CyPass placement and stability * Unplanned ocular surgical reintervention associated with CyPass placement and stability * Unplanned ocular surgical reintervention NOT associated with CyPass placement and stability (as defined in the protocol). 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
Time frame: Up to Month 36 postoperative
Population: ITT Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CyPass System | Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI) | 7.0 percentage of 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: * CyPass device explantation associated with CyPass placement and stability * Unplanned ocular surgical reintervention associated with CyPass placement and stability. 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
Time frame: Up to Month 36 postoperative
Population: ITT Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CyPass System | Percentage of Eyes With Ocular SSIs Associated With CyPass Placement and Stability | 2.3 percentage of eyes |
Secondary
Percentage of Eyes With Sight-threatening Adverse Events (AEs)
Sight-threatening adverse events, as specified in the protocol, included: * Persistent Best Corrected Distance Visual Acuity (BCDVA) loss of 3 lines or more * Endophthalmitis * Corneal decompensation * Retinal detachment * Severe choroidal hemorrhage or detachment * Aqueous misdirection. 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.
Time frame: Up to Month 36 postoperative
Population: ITT Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CyPass System | Percentage of Eyes With Sight-threatening Adverse Events (AEs) | 2.3 percentage of eyes |