Trial Outcomes & Findings for Long Term Safety Protocol for the AcrySof CACHET Phakic Lens (NCT NCT01497067)

Last Updated: 2019-07-02

Results Overview

A microscope was used to photograph corneal endothelial cells (cells on the back of the cornea). Three images at the center of the cornea were obtained and sent to a central reading center for analysis. All recorded data from images were used in the analysis. A higher value for density represents a healthier cornea.

Recruitment status

COMPLETED

Study phase

Target enrollment

657 participants

Primary outcome timeframe

Year 4 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57)

Results posted on

2019-07-02

Participant Flow

This study enrolled subjects at 20 investigative sites located in the US, 9 investigative sites located in the European Union, and 5 investigative sites located in Canada.

This reporting group includes all enrolled subjects.

Participant milestones

Participant milestones
Measure	CACHET ACRYSOF CACHET Phakic Lens (L-series) previously implanted
Overall Study STARTED	657
Overall Study COMPLETED	575
Overall Study NOT COMPLETED	82

Reasons for withdrawal

Reasons for withdrawal
Measure	CACHET ACRYSOF CACHET Phakic Lens (L-series) previously implanted
Overall Study Lost to Follow-up	56
Overall Study Adverse Event	3
Overall Study Patient decision unrel to Adverse Event	10
Overall Study Other	13

Baseline Characteristics

Long Term Safety Protocol for the AcrySof CACHET Phakic Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CACHET n=657 Participants ACRYSOF CACHET Phakic Lens (L-series) previously implanted
Age, Continuous	37.5 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	448 Participants n=5 Participants
Sex: Female, Male Male	209 Participants n=5 Participants
Race/Ethnicity, Customized White	597 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	14 Participants n=5 Participants
Race/Ethnicity, Customized Asian	34 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants
Race/Ethnicity, Customized Multi-racial	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Year 4 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57)

Population: All subjects enrolled in the study (Safety Analysis). Some subjects were implanted in both eyes and therefore 2 eyes were enrolled.

Outcome measures

Outcome measures
Measure	CACHET n=1123 eyes ACRYSOF CACHET Phakic Lens (L-series) previously implanted
Central Endothelial Cell Density (All Eyes) Year 4	2654.0 cells/mm^2 Standard Deviation 354.6
Central Endothelial Cell Density (All Eyes) Year 5	2639.0 cells/mm^2 Standard Deviation 324.2
Central Endothelial Cell Density (All Eyes) Year 5.5	2633.0 cells/mm^2 Standard Deviation 357.6
Central Endothelial Cell Density (All Eyes) Year 6	2551.0 cells/mm^2 Standard Deviation 362.3
Central Endothelial Cell Density (All Eyes) Year 6.5	2524.7 cells/mm^2 Standard Deviation 360.6
Central Endothelial Cell Density (All Eyes) Year 7	2504.9 cells/mm^2 Standard Deviation 365.8
Central Endothelial Cell Density (All Eyes) Year 7.5	2497.1 cells/mm^2 Standard Deviation 364.7
Central Endothelial Cell Density (All Eyes) Year 8	2465.0 cells/mm^2 Standard Deviation 384.2
Central Endothelial Cell Density (All Eyes) Year 8.5	2457.7 cells/mm^2 Standard Deviation 363.0
Central Endothelial Cell Density (All Eyes) Year 9	2409.6 cells/mm^2 Standard Deviation 388.4
Central Endothelial Cell Density (All Eyes) Year 9.5	2399.3 cells/mm^2 Standard Deviation 387.9
Central Endothelial Cell Density (All Eyes) Year 10	2377.5 cells/mm^2 Standard Deviation 398.0

Adverse Events

CACHET - Ocular

Serious events: 276 serious events

Other events: 0 other events

Deaths: 0 deaths

CACHET - Systemic

Serious events: 24 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Sr. Clinical Trial Lead, Surgical

Alcon Research

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	CACHET - Ocular n=1123 participants at risk All eyes previously implanted with ACRYSOF CACHET Phakic Lens (L-series)	CACHET - Systemic n=657 participants at risk All subjects previously implanted with ACRYSOF CACHET Phakic Lens (L-series)
Investigations Visual acuity tests abnormal	0.27% 3/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Cardiac disorders Coronary artery occlusion	0.00% 0/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.15% 1/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Cardiac disorders Myocardial infarction	0.00% 0/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.15% 1/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Ear and labyrinth disorders Vertigo	0.00% 0/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.15% 1/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Angle closure glaucoma	0.27% 3/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Cataract	1.8% 20/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Cataract cortical	0.71% 8/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Cataract nuclear	5.9% 66/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Cataract subcapsular	0.89% 10/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Choroidal neovascularisation	0.09% 1/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Corneal endothelial cell loss	8.8% 99/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Corneal oedema	0.09% 1/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Exophthalmos	0.09% 1/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Glaucoma	0.53% 6/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Iris adhesions	7.8% 88/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Iris atrophy	0.18% 2/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Iris disorder	0.18% 2/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Lens discolouration	0.18% 2/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Lens dislocation	0.09% 1/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Lenticular opacities	0.45% 5/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Macular oedema	0.09% 1/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Ocular hypertension	0.36% 4/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Open angle glaucoma	0.45% 5/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Pupillary deformity	0.53% 6/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Retinal degeneration	0.18% 2/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Retinal detachment	0.27% 3/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Retinal tear	0.18% 2/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Eye disorders Visual acuity reduced	0.98% 11/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
General disorders Accidental death	0.00% 0/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.15% 1/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
General disorders Device dislocation	0.62% 7/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
General disorders Eye complication associated with device	0.18% 2/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Infections and infestations Appendicitis	0.00% 0/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.30% 2/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Injury, poisoning and procedural complications Dislocation of vertebra	0.00% 0/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.15% 1/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.15% 1/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Investigations Intraocular pressure increased	0.98% 11/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.00% 0/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Metabolism and nutrition disorders Obesity	0.00% 0/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.15% 1/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.15% 1/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Musculoskeletal and connective tissue disorders Spinal deformity	0.00% 0/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.15% 1/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.15% 1/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/1123 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.	0.15% 1/657 • Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment. Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.