The objective of the study is to evaluate the safety and performance of the enVista trifocal intraocular lens when implanted in the capsular bag.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
165
enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally
enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally
Bausch Site 106
Calgary, Alberta, Canada
Bausch Site 102
Concord, Ontario, Canada
Bausch Site 103
Mississauga, Ontario, Canada
Bausch Site 105
Toronto, Ontario, Canada
Serious Adverse Events
All serious adverse events through Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation)
Time frame: Day 120 to Day 180 after second eye IOL implantation
Cumulative Rate of Secondary Surgical Interventions Due to the Optical Properties of the Lens
The cumulative rate of secondary surgical interventions (SSI) due to the optical properties of the lens, through Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation). The rate was determined as the number of eyes with an SSI related to the optical properties of the IOL divided by the total number of eyes.
Time frame: Day 120 to Day 180 after second eye IOL implantation
Photopic Uncorrected Distance Visual Acuity (UDVA) for First Implanted Eyes
Photopic uncorrected distance visual acuity (UDVA) for first implanted eyes at 4 m at Post.Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation)
Time frame: Day 120 to Day 180 after second eye IOL implantation
Photopic Uncorrected Near and Intermediate Visual Acuity (UNVA and UIVA) for First Implanted Eyes at 40 cm and 66 cm, Respectively
Photopic uncorrected near and intermediate visual acuity (UNVA and UIVA) for first implanted eyes at 40 cm and 66 cm, respectively, at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation)
Time frame: Day 120 to Day 180 after second eye IOL implantation
The Incidence of Adverse Events (AEs), Through Postoperative Visit 4 (Day 120 to Day 180 After Second Eye IOL Implantation), Compared to ISO Safety and Performance Endpoint Rates.
The incidence of adverse events (AEs), through Postoperative Visit 4 (Day 120 to Day 180 after second eye IOL implantation), compared to ISO Safety and Performance Endpoint rates as defined in ISO 11979-7:2018 and EN ISO 11979-7:2018 Annex E. The observed AE rate was calculated as 100 multiplied by the number of eyes with the specific treatment-emergent event divided by the number of implanted eyes.
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Bausch Site 107
Toronto, Ontario, Canada
Bausch Site 108
Vaughan, Ontario, Canada
Bausch Site 101
Boisbriand, Quebec, Canada
Bausch Site 113
Longueuil, Quebec, Canada
Bausch Site 104
Montreal, Quebec, Canada
Time frame: Day 120 to Day 180 after second eye IOL implantation
Incidence of Subjects Experiencing at Least One Severe Visual Disturbance
The incidence of Patient-Reported Outcomes Set subjects experiencing at least one severe visual disturbance, defined as the highest grade of severity or bothersomeness (separately) reported by subjects using the Quality of Vision (QoV) questionnaire at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation). Incidence was calculated as 100 multiplied by Count of Participants experiencing at least one severe visual disturbance divided by Number of Participants Analyzed.
Time frame: Day 120 to Day 180 after second eye IOL implantation
Photopic Contrast Sensitivity With Glare at Post-Operative Visit 4
Photopic contrast sensitivity with glare at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation). Binocular photopic (approximately 85 cd/m2) contrast sensitivity with glare was tested at spatial frequencies of 3, 6, 12 and 18 cycles per degree (cpd) and was assessed in log units.
Time frame: Day 120 to Day 180 after second eye IOL implantation
Mesopic Contrast Sensitivity With Glare at Post-Operative Visit 4
Mesopic contrast sensitivity with glare at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation). Binocular mesopic (2.5 to 3.2 cd/m2) contrast sensitivity with glare was tested at spatial frequencies of 1.5, 3, 6 and 12 cpd and was assessed in log units.
Time frame: Day 120 to Day 180 after second eye IOL implantation
Mesopic Contrast Sensitivity Without Glare at Post-Operative Visit 4
Mesopic contrast sensitivity without glare at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation). Binocular mesopic (2.5 to 3.2 cd/m2) contrast sensitivity without glare was tested at spatial frequencies of 1.5, 3, 6 and 12 cpd and was assessed in log units.
Time frame: Day 120 to Day 180 after second eye IOL implantation
IOL Rotation for All Eyes at Post-Operative Visit 4
IOL rotation for all eyes at Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation)
Time frame: Day 120 to Day 180 after second eye IOL implantation
Change From Baseline ( Preoperative ) in Uncorrected Photopic Near and Intermediate Visual Acuity (UNVA and UIVA) at 40 cm and 66 cm, Respectively, for First Implanted Eyes to Post-Operative Visit 4
Change from baseline ( preoperative ) in uncorrected photopic near and intermediate visual acuity (UNVA and UIVA) at 40 cm and 66 cm, respectively, for first implanted eyes to Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation)
Time frame: Day 120 to Day 180 after second eye IOL implantation