| Primary | Serious Adverse Events | All serious adverse events through Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation) | | Posted | | Count of Participants | | Participants | | Day 120 to Day 180 after second eye IOL implantation | | | | ID | Title | Description |
|---|
| OG000 | enVista MX60EFH Trifocal Intraocular Lens (IOL) | enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally | | OG001 | enVista MX60E Monofocal Intraocular Lens (IOL) | enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally |
| | | Title | Denominators | Categories |
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| Diverticulitis | | | | Neck pain | | |
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| Primary | 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. | | Posted | | Count of Units | | Eyes | | Day 120 to Day 180 after second eye IOL implantation | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | enVista MX60EFH Trifocal Intraocular Lens (IOL) | enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally | | OG001 | enVista MX60E Monofocal Intraocular Lens (IOL) | enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally |
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| Primary | 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) | | Posted | | Mean | Standard Deviation | logMAR | | Day 120 to Day 180 after second eye IOL implantation | | | | ID | Title | Description |
|---|
| OG000 | enVista MX60EFH Trifocal Intraocular Lens (IOL) | enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally | | OG001 | enVista MX60E Monofocal Intraocular Lens (IOL) | enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally |
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| Primary | 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) | | Posted | | Mean | Standard Deviation | logMAR | | Day 120 to Day 180 after second eye IOL implantation | | | | ID | Title | Description |
|---|
| OG000 | enVista MX60EFH Trifocal Intraocular Lens (IOL) | enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally | | OG001 | enVista MX60E Monofocal Intraocular Lens (IOL) | enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally |
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| Primary | 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. | | Posted | | Count of Units | | Eyes | | Day 120 to Day 180 after second eye IOL implantation | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | enVista MX60EFH Trifocal Intraocular Lens (IOL) | enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally |
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| Secondary | 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. | | Posted | | Count of Participants | | Participants | | Day 120 to Day 180 after second eye IOL implantation | | | | ID | Title | Description |
|---|
| OG000 | enVista MX60EFH Trifocal Intraocular Lens (IOL) | enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally | | OG001 | enVista MX60E Monofocal Intraocular Lens (IOL) | enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally |
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| Secondary | 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. | | Posted | | Mean | Standard Deviation | log value | | Day 120 to Day 180 after second eye IOL implantation | eyes | eyes | | ID | Title | Description |
|---|
| OG000 | enVista MX60EFH Trifocal Intraocular Lens (IOL) | enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally | | OG001 | enVista MX60E Monofocal Intraocular Lens (IOL) | enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally |
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| Secondary | 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. | | Posted | | Mean | Standard Deviation | log value | | Day 120 to Day 180 after second eye IOL implantation | eyes | eyes | | ID | Title | Description |
|---|
| OG000 | enVista MX60EFH Trifocal Intraocular Lens (IOL) | enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally | | OG001 | enVista MX60E Monofocal Intraocular Lens (IOL) | enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally |
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| Secondary | 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. | | Posted | | Mean | Standard Deviation | log value | | Day 120 to Day 180 after second eye IOL implantation | eyes | eyes | | ID | Title | Description |
|---|
| OG000 | enVista MX60EFH Trifocal Intraocular Lens (IOL) | enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally | | OG001 | enVista MX60E Monofocal Intraocular Lens (IOL) | enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally |
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| Secondary | 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) | | Posted | | Mean | Standard Deviation | degrees | | Day 120 to Day 180 after second eye IOL implantation | Eyes | Eyes | | ID | Title | Description |
|---|
| OG000 | enVista MX60EFH Trifocal Intraocular Lens (IOL) | enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally |
| | Units | Counts |
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| Participants | | | Eyes |
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| Secondary | 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) | | Posted | | Mean | Standard Deviation | logMAR | | Day 120 to Day 180 after second eye IOL implantation | | | | ID | Title | Description |
|---|
| OG000 | enVista MX60EFH Trifocal Intraocular Lens (IOL) | enVista MX60EFH trifocal intraocular lenses (IOLs): enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally | | OG001 | enVista MX60E Monofocal Intraocular Lens (IOL) | enVista MX60E monofocal intraocular lenses (IOLs): enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally |
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