NCT03273907

Post Approval Study of the CyPass System

Terminated NA Results posted Last updated 16 February 2024

What this trial tests

NA trial testing CyPass Micro-Stent implanted with CyPass 241-S applier in Primary Open-angle Glaucoma in 79 participants. Terminated before completion.

Timeline

12 October 2017

Primary endpoint
31 August 2021

31 August 2021

Quick facts

Lead sponsor	Alcon Research
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	79
Start date	12 October 2017
Primary completion	31 August 2021
Estimated completion	31 August 2021
Sites	20 locations across United States

Drugs / interventions tested

• CyPass Micro-Stent implanted with CyPass 241-S applier
• Cataract surgery — full drug profile →

Conditions studied

• Primary Open-angle Glaucoma — all drugs for Primary Open-angle Glaucoma →
• Cataract — all drugs for Cataract →

Sponsor

Alcon Research — full company profile →

Who can join

45 and older, any sex, with Primary Open-angle Glaucoma or Cataract. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36 Primary · 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 t

Group	Value	95% CI
CyPass System	2.3

Mean Change in IOP From Baseline at Month 36 Secondary · 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.

Group	Value	95% CI
CyPass System	-3.71	± 4.881

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 Secondary · 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.

Group	Value	95% CI
CyPass System	41.2	24.6 – 59.3

Percentage of Eyes Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg at Month 36 Secondary · Month 36 postoperative

Intraocular pressure (IOP) was assessed by Goldman tonometry and measured in millimeters mercury (mmHg). Only one eye per subject was implanted.

Group	Value	95% CI
CyPass System	61.8	43.6 – 77.8

Percentage of Eyes With Sight-threatening Adverse Events (AEs) Secondary · 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.

Group	Value	95% CI
CyPass System	2.3	0.1 – 12.3

Percentage of Eyes With Ocular Secondary Surgical Interventions (SSI) Secondary · 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

Group	Value	95% CI
CyPass System	7.0	1.5 – 19.1

Percentage of Eyes With Ocular SSIs Associated With CyPass Placement and Stability Secondary · 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

Group	Value	95% CI
CyPass System	2.3	0.1 – 12.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pretreatment

Serious: 0/43 (0%)

Deaths: 0/43

CyPass Study Eye

Serious: 4/43 (9%)

Deaths: 0/43

CyPass Systemic

Serious: 7/43 (16%)

Deaths: 1/43

Serious adverse events (13 terms)

Reaction	System	Pretreatment	CyPass Study Eye	CyPass Systemic
Intraocular pressure increased	Investigations	—	—	—
Paracentesis eye	Investigations	—	—	—
Cardiac failure	Cardiac disorders	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—
Visual acuity reduced	Eye disorders	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—
Cholecystitis	Hepatobiliary disorders	—	—	—
Upper limb fracture	Injury, poisoning and procedural complications	—	—	—
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Visual field defect	Nervous system disorders	—	—	—
Renal failure	Renal and urinary disorders	—	—	—
Glaucoma drainage device placement	Surgical and medical procedures	—	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Pretreatment	CyPass Study Eye	CyPass Systemic
Cataract operation	Surgical and medical procedures	—	—	—
Posterior capsule opacification	Eye disorders	—	—	—
Intraocular pressure increased	Investigations	—	—	—
Visual acuity reduced	Eye disorders	—	—	—
Visual field defect	Nervous system disorders	—	—	—

Most-reported serious reactions: Intraocular pressure increased, Paracentesis eye, Cardiac failure, Cardiac failure congestive, Visual acuity reduced, Gastrointestinal haemorrhage, Cholecystitis, Upper limb fracture.

Data from ClinicalTrials.gov NCT03273907 adverse events section.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Minimally Invasive Glaucoma Surgical Techniques for Open-Angle Glaucoma: An Overview of Cochrane Systematic Reviews and Network Meta-analysis.
   Bicket AK, Le JT, Azuara-Blanco A, Gazzard G, et al · · 2021 · cited 77× · PMID 34264292 · DOI 10.1001/jamaophthalmol.2021.2351
2. Ab interno supraciliary microstent surgery for open-angle glaucoma.
   Sandhu A, Jayaram H, Hu K, Bunce C, et al · · 2021 · cited 13× · PMID 34049422 · DOI 10.1002/14651858.cd012802.pub2