Clinical trial NCT04224155: Clinical Study to Evaluate the Safety and Performance of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2020-01-13
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Serious Adverse Events
timeFrame: Day 120 to Day 180 after second eye IOL implantation
measure: Cumulative Rate of Secondary Surgical Interventions Due to the Optical Properties of the Lens
timeFrame: Day 120 to Day 180 after second eye IOL implantation
measure: Photopic Uncorrected Distance Visual Acuity (UDVA) for First Implanted Eyes
timeFrame: Day 120 to Day 180 after second eye IOL implantation
measure: Photopic Uncorrected Near and Intermediate Visual Acuity (UNVA and UIVA) for First Implanted Eyes at 40 cm and 66 cm, Respectively
timeFrame: Day 120 to Day 180 after second eye IOL implantation
measure: 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.
timeFrame: Day 120 to Day 180 after second eye IOL implantation
Secondary outcomes:
measure: Incidence of Subjects Experiencing at Least One Severe Visual Disturbance
timeFrame: Day 120 to Day 180 after second eye IOL implantation
measure: Photopic Contrast Sensitivity With Glare at Post-Operative Visit 4
timeFrame: Day 120 to Day 180 after second eye IOL implantation
measure: Mesopic Contrast Sensitivity With Glare at Post-Operative Visit 4
timeFrame: Day 120 to Day 180 after second eye IOL implantation
measure: Mesopic Contrast Sensitivity Without Glare at Post-Operative Visit 4
timeFrame: Day 120 to Day 180 after second eye IOL implantation
measure: IOL Rotation for All Eyes at Post-Operative Visit 4
timeFrame: Day 120 to Day 180 after second eye IOL implantation
measure: 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
timeFrame: Day 120 to Day 180 after second eye IOL implantation
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Bausch Site 106
state: Alberta
city: Concord
country: Canada
facility: Bausch Site 102
state: Ontario
city: Mississauga
country: Canada
facility: Bausch Site 103
state: Ontario
city: Toronto
country: Canada
facility: Bausch Site 105
state: Ontario
city: Toronto
country: Canada
facility: Bausch Site 107
state: Ontario
city: Vaughan
country: Canada
facility: Bausch Site 108
state: Ontario
city: Boisbriand
country: Canada
facility: Bausch Site 101
state: Quebec
city: Longueuil
country: Canada
facility: Bausch Site 113
state: Quebec
city: Montréal
country: Canada
facility: Bausch Site 104
state: Quebec
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Anya Loncaric
role: STUDY_DIRECTOR
References: