Clinical Study to Evaluate the Safety and Performance of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction

Study Overview
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Brief Summary
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The objective of the study is to evaluate the safety and performance of the enVista trifocal intraocular lens when implanted in the capsular bag.

Official Title
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A Prospective, Multicenter, Randomized, Masked, Controlled Clinical Study to Evaluate the Safety and Performance of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction

Conditions
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Cataract

Intervention / Treatment
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* Device: enVista MX60EFH trifocal intraocular lenses (IOLs)
* Device: enVista MX60E monofocal intraocular lenses (IOLs)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be 18 years of age or older on the date the Informed Consent Form (ICF) is signed. Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) and authorization as appropriate for local privacy regulations. Subjects must have a Best-corrected Distance Visual Acuity (CDVA) equal to or worse than 20/40 in at least one eye, with or without a glare source, due to a clinically significant cataract (cortical, nuclear, subcapsular, or combination) that is considered amenable to treatment with standard phacoemulsification cataract extraction and capsular IOL implantation. Subjects must have a Best-corrected Distance Visual Acuity (CDVA) projected to be equal to or better than 20/32 after IOL implantation in each eye, as determined by the medical judgment of the Investigator or measured by potential acuity meter (PAM) testing, if necessary. Subjects must have clear intraocular media other than the cataract in both eyes. Subjects must have discontinued use of contact lenses for at least 2 weeks (for hard lenses) or 3 days (for soft lenses) prior to the pre-operative examination and must be willing to refrain from use of contact lenses throughout the clinical study. Contact lens wearers must demonstrate a stable refraction (within ±0.50 D for both sphere and cylinder) in both eyes, as determined by distance manifest refraction on two consecutive examination dates after discontinuation of contact lens wear. Subjects must require an IOL power from +16.0 diopter (D) to +27.0 D in both eyes. Subjects must be willing and able to comply with all treatment and follow-up study visits and procedures, and to undergo second eye surgery within 7-30 days of the first eye surgery. Exclusion Criteria: Subjects who have participated in an investigational drug or device clinical investigation within 30 days prior to entry into this study and/or will participate in another investigation during the period of study participation. Subjects who have any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in either eye. . ' Subjects who have significant anterior segment pathology that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, traumatic cataract, lens subluxation, traumatic zonulolysis, zonular dialysis, evident zonular weakness or dehiscence, hypermature or brunescent cataract, etc.) in either eye. Subjects who have uncontrolled glaucoma in either eye. Subjects who have previous retinal detachment or clinically significant retinal pathology involving the macula in either eye. Subjects who have proliferative or non-proliferative diabetic retinopathy in either eye. Subjects who have a congenital ocular anomaly (e.g., aniridia, congenital cataract) in either eye. Subjects with instability of keratometry or biometry measurements. Subjects using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure within 30 days of enrollment or during the study. Subjects who have current or previous usage of an alpha-I-selective adrenoceptor blocking agent or an antagonist of alpha IA adrenoceptor (e.g., Flomax® (tamsulosin HCI), Terazosin, or Cardura). Subjects who have a history of chronic or recurrent inflammatory eye disease (e.g., iritis, scleritis, iridocyclitis, or rubeosis iridis) in either eye. Subjects who have a visual disorder, other than cataracts, that could potentially cause future acuity losses to a level of 20/ I 00 or worse in either eye. Subjects who have had previous intraocular or corneal surgery in either eye, with the exception of laser trabeculoplasty. Subjects with any preoperative infectious conjunctivitis, keratitis, or uveitis in either eye. Subjects who have a preoperative corneal astigmatism> 1.0 D in either eye as measured by corneal topography, irregular astigmatism, or skewed radial axis (note: corneal incisions intended specifically to reduce astigmatism are not allowed during the study). Subjects who cannot achieve a minimum pharmacologic pupil dilation of 5.0 mm in both eyes. Subjects who may be expected to require a combined or other secondary surgical procedure in either eye. Females of childbearing potential (those who are not surgically sterilized or at least 12 months postmenopausal) are excluded from enrollment in the study if they are nursing, lactating, currently pregnant or plan to become pregnant during the study. Females of childbearing potential must be willing to practice effective contraception for the duration of the study. Subjects with any other serious ocular pathology or underlying systemic medical condition (e.g., uncontrolled diabetes) or circumstance that, based on the Investigator's judgment, poses a concern for the subjects' safety or could confound the results of the study. Subjects with abnormal pupillary dilation dynamics (as determined by the medical judgment of the investigator) or eccentric or ectopic pupils in either eye.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: enVista MX60EFH trifocal intraocular lens (IOL)<br> | Device: enVista MX60EFH trifocal intraocular lenses (IOLs)<br>* enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally<br>|
| Active Comparator: enVista MX60E monofocal intraocular lens (IOL)<br> | Device: enVista MX60E monofocal intraocular lenses (IOLs)<br>* enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all serious adverse events, including secondary surgical interventions (SSls) related to the optical properties of the IOL | The incidence of all serious adverse events, including secondary surgical interventions (SSls) related to the optical properties of the IOL, through Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation) | 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 due to the optical properties of the lens, through Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation) | Day 120 to Day 180 after second eye IOL implantation | 
| Incidence of adverse events | The incidence of adverse events, through Post-Operative Visit 4 (Day 120 to Day 180 after second eye [OL implantation), compared to ISO Safety and Performance Endpoint (SPE) rates as defined in ISO 11979-7:2018 Annex E | 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) | 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) | Day 120 to Day 180 after second eye IOL implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of subjects experiencing at least one severe visual disturbance | The incidence of 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 through Post-Operative Visit 4 (Day 120 to Day 180 after second eye IOL implantation) | 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) | 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) | 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) | 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) | 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) | Day 120 to Day 180 after second eye IOL implantation |