Primary Open-angle GlaucomaNCT03273907
Post Approval Study of the CyPass System
A study testing CyPass Micro-Stent implanted with CyPass 241-S applier and Cataract surgery in people with Primary Open-angle Glaucoma and Cataract, run by Alcon Research at 20 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Primary Open-angle Glaucoma, Cataract
- What is being tested?
- CyPass Micro-Stent implanted with CyPass 241-S applier and Cataract surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 20 sitesUnited States
- Study dates
- 12 Oct 2017to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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 exclusion criteria may apply.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Alcon Investigative Site
Austin, Texas, 78731
Alcon Investigative Site
Bala-Cynwyd, Pennsylvania, 19004
Alcon Investigative Site
Bellevue, Washington, 98004-3012
Alcon Investigative Site
Chambersburg, Pennsylvania, 17201
Alcon Investigative Site
El Paso, Texas, 79902
Alcon Investigative Site
Fort Collins, Colorado, 80528
Alcon Investigative Site
Fraser, Michigan, 48026
Alcon Investigative Site
Gainesville, Georgia, 30501
Alcon Investigative Site
Garden City, Kansas, 67846
Alcon Investigative Site
Houston, Texas, 77030
Alcon Investigative Site
Jacksonville, Florida, 32256
Alcon Investigative Site
Kenosha, Wisconsin, 53142
Alcon Investigative Site
Marietta, Georgia, 30060
Alcon Investigative Site
Orange, California, 92868
Alcon Investigative Site
Panama City, Florida, 32405
Alcon Investigative Site
Phoenix, Arizona, 85016
Alcon Investigative Site
Racine, Wisconsin, 53405
Alcon Investigative Site
St Louis, Missouri, 63131
Alcon Investivative Site
St Louis, Missouri, 63141
Alcon Investigative Site
Vineland, New Jersey, 08361
About this study
Official title: Post Approval Study of the CyPass System in Patients With Primary Open Angle Glaucoma Undergoing Cataract Surgery
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).
Read the 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.
- Conditions
- Primary Open-angle Glaucoma, Cataract
- Being tested
- CyPass Micro-Stent implanted with CyPass 241-S applier, Cataract surgery
- Keywords
- CyPass Micro-Stent
- Medical subject headings
- Glaucoma, Open-Angle, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyPass Micro-Stent implanted with CyPass 241-S applierDevice
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.
Cataract surgeryProcedure or surgery
Cataract surgery, followed by implantation of the CyPass Micro-Stent in one eye (the study eye) at the surgery visit
| Study group | Role | What they receive |
|---|---|---|
| CyPass System | Experimental | CyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery Receives: Device: CyPass Micro-Stent implanted with CyPass 241-S applier; Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to Month 36 postoperative
Secondary outcomes (6)
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.
Measured: 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
Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement.
Measured: 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.
Measured: Month 36 postoperative
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.
Measured: 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:
- 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
Measured: 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:
- 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
Measured: Up to Month 36 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start12 Oct 2017
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Why it stopped: Voluntary market withdrawal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Open-angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Clinical Trial Lead, Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273907
- Sponsor's protocol ID
- GLD122c-C001
- Status last verified
- Aug 2022
- First submitted
- 5 Sep 2017
- Last updated
- 16 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Approval Study of the CyPass System in Patients With Primary Open Angle Glaucoma Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT03273907
- Acronym / sponsor ID
- GLD122c-C001
- Conditions
- Primary Open-angle Glaucoma, Cataract
- Keywords
- CyPass Micro-Stent
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Voluntary market withdrawal
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Posted 21 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CyPass System | Experimental | Device: CyPass Micro-Stent implanted with CyPass 241-S applier, Procedure: Cataract surgeryCyPass Micro-Stent implanted with CyPass 241-S applier in the angle of the eye during cataract surgery |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyPass Micro-Stent implanted with CyPass 241-S applierCyPass 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. | Device | CyPass System |
| Cataract surgeryCataract surgery, followed by implantation of the CyPass Micro-Stent in one eye (the study eye) at the surgery visit | Procedure or surgery | CyPass System |
Primary outcome
Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36
Time frame: 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).
6 secondary outcomes
Mean Change in IOP From Baseline at Month 36
Time frame: 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
Time frame: Baseline, Month 36 postoperative
Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36
Time frame: Month 36 postoperative
Percentage of Eyes With Sight-threatening Adverse Events (AEs)
Time frame: Up to Month 36 postoperative
Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI)
Time frame: Up to Month 36 postoperative
Percentage of Eyes With Ocular SSIs Associated With CyPass Placement and Stability
Time frame: Up to Month 36 postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Primary Open-angle Glaucoma
Active, not recruiting
OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
Primary Open Angle Glaucoma
Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle
Not yet recruitingPhase 4
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
Glaucoma, Glaucoma, Open-Angle
Not yet recruitingPhase 2
Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial)
Glaucoma, Open-angle, Primary Open Angle Glaucoma (POAG)
Enrolling by invitationPhase 1/2
Topical Insulin for Glaucoma (TING2)
Open Angle Glaucoma, Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sr. Clinical Trial Lead, Surgical study director
Alcon Research, LLC
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyPass Micro-Stent implanted with CyPass 241-S applier and Cataract surgery in people with Primary Open-angle Glaucoma and Cataract, run by Alcon Research at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36 (time frame: Up to Month 36 postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.