NCT04629521: COMPASS XXT

Additional Long-Term Follow-up for Subjects Implanted With a CyPass® Micro-Stent

Completed NA Results posted Last updated 26 April 2024

What this trial tests

NA trial testing CyPass Micro-Stent in Primary Open Angle Glaucoma in 54 participants. Completed in 5 April 2023.

Timeline

21 December 2020

Primary endpoint
5 April 2023

5 April 2023

Quick facts

Lead sponsor	Alcon Research
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	54
Start date	21 December 2020
Primary completion	5 April 2023
Estimated completion	5 April 2023
Sites	12 locations across United States

Drugs / interventions tested

• CyPass Micro-Stent
• 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 Sight-threatening Adverse Events (AEs) Primary · Month 96 (Year 8) to Month 120 (Year 10) postoperative

An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test product). This analysis was performed using data from visits in the COMPASS XXT study and includes sight-threatening adverse events as specified in the protocol. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Persistent BCDVA loss of 3 lines or more compared to best BCDVA collected at any time during study

Group	Value	95% CI
Cataract Surgery + CyPass	18.5	9.3 – 31.4

Endophthalmitis

Group	Value	95% CI
Cataract Surgery + CyPass	0.0	0.0 – 6.6

Corneal decompensation

Group	Value	95% CI
Cataract Surgery + CyPass	0.0	0.0 – 6.6

Retinal detachment

Group	Value	95% CI
Cataract Surgery + CyPass	0.0	0.0 – 6.6

Severe choroidal hemorrhage or detachment

Group	Value	95% CI
Cataract Surgery + CyPass	0.0	0.0 – 6.6

Aqueous misdirection

Group	Value	95% CI
Cataract Surgery + CyPass	0.0	0.0 – 6.6

Percentage of Eyes With Ocular Adverse Events Primary · Month 96 (Year 8) to Month 120 (Year 10) postoperative

An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test product). This analysis was performed using data from visits in the COMPASS XXT study and includes ocular events other than sight-threatening adverse events. No hypothesis testing was prespecified for this outcome measure. One eye (study eye) contributed data to this analysis.

Visual Acuity Reduced

Group	Value	95% CI
Cataract Surgery + CyPass	38.9	25.9 – 53.1

Visual Field Defect

Group	Value	95% CI
Cataract Surgery + CyPass	37.0	24.3 – 51.3

Corneal Endothelial Cell Loss

Group	Value	95% CI
Cataract Surgery + CyPass	11.1	4.2 – 22.6

Post Procedural Complication

Group	Value	95% CI
Cataract Surgery + CyPass	9.3	3.1 – 20.3

Device Placement Issue

Group	Value	95% CI
Cataract Surgery + CyPass	5.6	1.2 – 15.4

Hypotony Of Eye

Group	Value	95% CI
Cataract Surgery + CyPass	3.7	0.5 – 12.7

Intraocular Pressure Increased

Group	Value	95% CI
Cataract Surgery + CyPass	3.7	0.5 – 12.7

Optic Nerve Cup/Disc Ratio

Group	Value	95% CI
Cataract Surgery + CyPass	3.7	0.5 – 12.7

Central Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation Primary · Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can v

Month 96 (Year 8)

Group	Value	95% CI
Cataract Surgery + CyPass	1802.49	± 520.329

Month 108 (Year 9)

Group	Value	95% CI
Cataract Surgery + CyPass	1668.80	± 707.729

Month 120 (Year 10)

Group	Value	95% CI
Cataract Surgery + CyPass	1574.73	± 714.996

Central Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval Primary · Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can v

Month 96 (Year 8)

Group	Value	95% CI
Cataract Surgery + CyPass	1802.49	1321.26 – 2283.71

Month 108 (Year 9)

Group	Value	95% CI
Cataract Surgery + CyPass	1668.80	1448.26 – 1889.35

Month 120 (Year 10)

Group	Value	95% CI
Cataract Surgery + CyPass	1574.73	1339.73 – 1809.74

Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) Primary · Month 96 (Year 8) postoperative

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can v

0 percentile

Group	Value	95% CI
Cataract Surgery + CyPass	909.7

5th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	909.7

25th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	1412.5

50th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	1959.2

75th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2185.3

95th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2460.0

100th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2460.0

Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) Primary · Month 108 (Year 9) postoperative

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can v

0 percentile

Group	Value	95% CI
Cataract Surgery + CyPass	458.8

5th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	561.0

25th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	805.7

50th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	1867.0

75th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2222.8

95th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2546.0

100th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2660.8

Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) Primary · Month 120 (Year 10) postoperative

Central ECD refers to the number of endothelial cells present per square millimeter in the central cornea. This measurement helps in monitoring the progression of corneal diseases, particularly in conditions where there is a gradual loss of endothelial cells leading to corneal edema and vision loss. Central ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of the corneal endothelial cells in the central cornea. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, although this can v

0 percentile

Group	Value	95% CI
Cataract Surgery + CyPass	413.5

5th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	415.7

25th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	796.6

50th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	1640.0

75th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2165.3

95th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2597.5

100th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2800.8

Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation Primary · Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, althou

Month 96 (Year 8)

Group	Value	95% CI
Cataract Surgery + CyPass	1844.51	± 684.727

Month 108 (Year 9)

Group	Value	95% CI
Cataract Surgery + CyPass	1739.44	± 779.814

Month 120 (Year 10)

Group	Value	95% CI
Cataract Surgery + CyPass	1688.74	± 803.605

Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval Primary · Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, althou

Month 96 (Year 8)

Group	Value	95% CI
Cataract Surgery + CyPass	1844.51	1211.25 – 2477.78

Month 108 (Year 9)

Group	Value	95% CI
Cataract Surgery + CyPass	1739.44	1496.44 – 1982.45

Month 120 (Year 10)

Group	Value	95% CI
Cataract Surgery + CyPass	1688.74	1388.87 – 1988.61

Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8) Primary · Month 96 (Year 8) postoperative

Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, althou

0 percentile

Group	Value	95% CI
Cataract Surgery + CyPass	489.7

5th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	489.7

25th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	1390.6

50th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2132.7

75th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2227.0

95th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2465.2

100th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2465.2

Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9) Primary · Month 108 (Year 9) postoperative

Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, althou

0 percentile

Group	Value	95% CI
Cataract Surgery + CyPass	449.5

5th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	510.0

25th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	1024.5

50th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2020.5

75th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2341.0

95th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2772.0

100th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2814.0

Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10) Primary · Month 120 (Year 10) postoperative

Peripheral ECD refers to the number of endothelial cells present per square millimeter in the peripheral cornea. This measurement is important for detecting peripheral corneal diseases, monitoring progression of corneal diseases, assessing the impact of contact lens wear, and ensuring optimal surgical planning (i.e., corneal transplantation). Peripheral ECD was assessed using specular microscopy, a non-invasive imaging technique that allows for visualization and quantification of endothelial cells. A normal ECD in adults typically ranges between 2500 to 3000 cells per square millimeter, althou

0 percentile

Group	Value	95% CI
Cataract Surgery + CyPass	353.3

5th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	477.0

25th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	856.5

50th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	1865.4

75th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2345.5

95th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	2637.3

100th percentile

Group	Value	95% CI
Cataract Surgery + CyPass	3183.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events (AEs) were collected from time of consent (COMPASS XXT) until time of study exit (COMPASS XXT), from 1 day to 2 years depending on point of enrollment.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cataract Surgery + CyPass - Ocular Adverse Events

Serious: 12/54 (22%)

Deaths: 0/54

Cataract Surgery + CyPass - Systemic Adverse Events

Serious: 2/54 (4%)

Deaths: 1/54

Serious adverse events (6 terms)

Reaction	System	Cataract Surgery + CyPass …	Cataract Surgery + CyPass …
Visual Acuity Reduced	Eye disorders	—	—
Visual Field Defect	Nervous system disorders	—	—
Trabeculectomy	Surgical and medical procedures	—	—
Death	General disorders	—	—
Post Procedural Complication	Injury, poisoning and procedural complications	—	—
Trabeculoplasty	Surgical and medical procedures	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Cataract Surgery + CyPass …	Cataract Surgery + CyPass …
Visual Field Defect	Nervous system disorders	—	—
Visual Acuity Reduced	Eye disorders	—	—
Corneal Endothelial Cell Loss	Eye disorders	—	—
Post Procedural Complication	Injury, poisoning and procedural complications	—	—
Device Placement Issue	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Visual Acuity Reduced, Visual Field Defect, Trabeculectomy, Death, Post Procedural Complication, Trabeculoplasty.

Data from ClinicalTrials.gov NCT04629521 adverse events section.

Sponsor's own description

The purpose of this study is to assess long-term (10 years post-CyPass implantation) status of the corneal endothelium in subjects who were implanted with the CyPass Micro-Stent in the COMPASS trial.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.