N/A N=54 Other

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

Primary Open Angle Glaucoma · Cataract

Bottom Line

View on ClinicalTrials.gov: NCT04629521 ↗

Enrolled (actual)

Serious AEs

13.0%

Results posted

Apr 2024

Primary outcome: Primary: Percentage of Eyes With Sight-threatening Adverse Events (AEs) — 18.5; 0.0; 0.0; 0.0 percentage of eyes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CyPass Micro-Stent (Device); Cataract Surgery (Procedure)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Eyes With Sight-threatening Adverse Events (AEs)	18.5; 0.0; 0.0; 0.0; 0.0; 0.0	—
PRIMARY Percentage of Eyes With Ocular Adverse Events	38.9; 37.0; 11.1; 9.3; 5.6; 3.7	—
PRIMARY Central Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation	1802.49; 1668.80; 1574.73	—
PRIMARY Central Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval	1802.49; 1668.80; 1574.73	—
PRIMARY Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8)	909.7; 909.7; 1412.5; 1959.2; 2185.3; 2460.0	—
PRIMARY Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9)	458.8; 561.0; 805.7; 1867.0; 2222.8; 2546.0	—
PRIMARY Central Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10)	413.5; 415.7; 796.6; 1640.0; 2165.3; 2597.5	—
PRIMARY Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation	1844.51; 1739.44; 1688.74	—
PRIMARY Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval	1844.51; 1739.44; 1688.74	—
PRIMARY Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8)	489.7; 489.7; 1390.6; 2132.7; 2227.0; 2465.2	—
PRIMARY Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9)	449.5; 510.0; 1024.5; 2020.5; 2341.0; 2772.0	—
PRIMARY Peripheral (Nasal) Endothelial Cell Density (ECD) Reported by Percentile - Month 120 (Year 10)	353.3; 477.0; 856.5; 1865.4; 2345.5; 2637.3	—
PRIMARY Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Mean and Standard Deviation	28.19; 29.25; 30.57	—
PRIMARY Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 96 (Year 8)	23.8; 23.8; 24.8; 28.2; 31.0; 32.3	—
PRIMARY Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 108 (Year 9)	8.0; 20.5; 27.0; 29.4; 32.2; 36.3	—
PRIMARY Central Endothelial Cell Coefficient of Variation (CECCV) Reported by Percentile - Month 120 (Year 10)	16.5; 21.5; 27.8; 30.8; 33.8; 38.8	—
PRIMARY Central Endothelial Hexagonality (CEH) Reported by Mean and Standard Deviation	64.33; 60.96; 62.09	—
PRIMARY Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 96 (Year 8)	57.7; 57.7; 59.3; 66.0; 68.3; 71.5	—
PRIMARY Central Endothelial Hexagonality (CEH) Reported by Percentile - Month 108 (Year 9)	41.0; 44.3; 57.8; 60.8; 65.7; 72.5	—
PRIMARY Central Endothelial Hexagonality Reported by Percentile - Month 120 (Year 10)	43.3; 44.0; 57.8; 63.4; 68.2; 75.8	—
PRIMARY Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation	-612.31; -762.63; -819.62	—
PRIMARY Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval	-612.31; -762.63; -819.62	—
PRIMARY Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8)	-1802.6; -1802.6; -1246.7; -444.5; 60.2; 161.8	—
PRIMARY Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9)	-2028.0; -1893.8; -1450.1; -590.3; -198.3; 308.0	—
PRIMARY Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10)	-1937.5; -1873.7; -1416.4; -907.6; -232.0; 253.8	—
PRIMARY Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation	-22.77; -30.60; -33.57	—
PRIMARY Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval	-22.77; -30.60; -33.57	—
PRIMARY Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 96 (Year 8)	-66.5; -66.5; -46.9; -16.9; 3.8; 7.0	—
PRIMARY Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 108 (Year 9)	-79.9; -74.8; -65.5; -24.9; -8.1; 18.0	—
PRIMARY Percent Change in Central Endothelial Cell Density (ECD) From COMPASS Trial Baseline Visit Reported by Percentile - Month 120 (Year 10)	-81.9; -80.1; -61.9; -35.8; -8.6; 16.7	—
PRIMARY Percentage of Eyes According to Central Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared	0.0; 0.0; 0.0; 1.9; 0.0; 9.7	—
PRIMARY Percentage of Eyes According to Central Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
PRIMARY Percentage of Eyes According to Central Endothelial Cell Loss (ECL) Greater Than 30 Percent From Baseline	9.6; 9.4; 13.0; 9.4; 0.0; 19.4	—
PRIMARY Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <1000 Cells Per Millimeter Squared	14.3; 23.8; 30.0	—
PRIMARY Percentage of Eyes According to Peripheral Endothelial Cell Density (ECD) <500 Cells Per Millimeter Squared	14.3; 4.8; 6.7	—
PRIMARY Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation	-267.77; -23.80; -118.83; -63.57; -95.54; -138.10	—
PRIMARY Annualized Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval	-267.77; -23.80; -118.83; -63.57; -95.54; -138.10	—
PRIMARY Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and Standard Deviation	-10.15; -1.24; -4.86; -2.72; -5.14; -8.52	—
PRIMARY Annualized Percent Rate of Change in Central Endothelial Cell Density (ECD) at Each Year of Observation Reported by Mean and 95 Percent Confidence Interval	-10.15; -1.24; -4.86; -2.72; -5.14; -8.52	—
PRIMARY Number of Corneal Sequelae Events Associated With Endothelial Cell Loss (ECL)	—	—
PRIMARY Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation	1913.03; 2159.24; 2154.11; 2368.27; 2035.25; 1769.03	—
PRIMARY Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 3	1364.2; 1230.3; 1592.5; 2179.0; 2029.8; 1364.2	—
PRIMARY Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 6	1361.1; 2394.5; 1418.0; 1672.0; 1693.7; 1965.6	—
PRIMARY Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 12 (Year 1)	1357.7; 1756.3; 1388.7; 1340.5; 1659.6; 1285.5	—
PRIMARY Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 24 (Year 2)	1350.2; 2370.2; 1301.3; 1526.7; 1390.0; 694.5	—
PRIMARY Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 36 (Year 3)	2324.5; 2197.2; 2324.5; 2197.2; 2324.5; 2197.2	—
PRIMARY Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 48 (Year 4)	1684.7; 2555.7; 1678.7; 1524.0; 752.5; 716.5	—
PRIMARY Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 60 (Year 5)	1683.7; 2322.5; 1345.3; 1109.0; 741.7; 1683.7	—
PRIMARY Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8)	1660.7; 1412.5; 2185.3; 1959.2; 909.7; 1660.7	—
PRIMARY Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9)	547.5; 1438.5; 699.3; 458.8; 568.3; 547.5	—
PRIMARY Central Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10)	483.5; 796.6; 624.7; 413.5; 415.7; 483.5	—
PRIMARY Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Mean and Standard Deviation	2132.70; 1390.60; 2227.00; 2103.20; 1477.45; 2062.49	—
PRIMARY Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 96 (Year 8)	2132.7; 1390.6; 2227.0; 1995.7; 489.7; 2132.7	—
PRIMARY Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 108 (Year 9)	516.5; 1373.0; 569.0; 449.5; 479.2; 516.5	—
PRIMARY Peripheral Endothelial Cell Density (ECD) by Number of Rings Observed at the Visit Reported by Percentile - Month 120 (Year 10)	526.5; 1512.7; 647.7; 477.0; 353.3; 526.5	—
PRIMARY Number of Secondary Surgical Intervention (SSI) Events to Modify the Device Position (eg, Repositioning, Trimming, Explantation)	—	—
PRIMARY Percentage of Eyes With CyPass Micro-Stent Movement and/or Malposition	7.4	—
PRIMARY Number of Corneal Adverse Events Caused by CyPass MicroStent	—	—
PRIMARY Number of Events of Best Corrected Visual Acuity (BCVA) Loss of 10 Letters or More	21	—
PRIMARY Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported by Mean and Standard Deviation	2.379; -1.176; -2.321	—
PRIMARY Percentage of Eyes With Change in Visual Field Mean Deviation From COMPASS Trial Screening Visit Reported Categorically - 2 Decibel (dB)	42.9; 51.7; 0.0; 9.8; 51.2; 39.0	—
PRIMARY Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and Standard Deviation	1.9; 0.0; 4.1	—
PRIMARY Change in Central Corneal Thickness (CCT) From COMPASS Trial Baseline Visit Reported by Mean and 95 Percent Confidence Interval	1.9; 0.0; 4.1	—

Summary

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.

Eligibility Criteria

Key Inclusion Criteria

Implantation with a CyPass Micro-Stent as a participant in the COMPASS trial (NCT01085357) (Transcend Medical, Incorporated, Study Number TMI-09-01).
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.
Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria

Inability to comply with the protocol or required follow-up visit/procedures.
Other protocol-defined exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04629521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.