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

NCT ID: NCT04224155

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-10
• Study Completion Date: 2022-06-14

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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

enVista MX60EFH trifocal intraocular lens (IOL)

Group Type: EXPERIMENTAL

enVista MX60EFH trifocal intraocular lenses (IOLs)

Intervention Type: DEVICE

enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally

enVista MX60E monofocal intraocular lens (IOL)

Group Type: ACTIVE_COMPARATOR

enVista MX60E monofocal intraocular lenses (IOLs)

Intervention Type: DEVICE

enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally

Interventions

enVista MX60EFH trifocal intraocular lenses (IOLs)

enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally

Intervention Type: DEVICE

enVista MX60E monofocal intraocular lenses (IOLs)

enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anya Loncaric

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Bausch Site 106

Calgary, Alberta, Canada

Bausch Site 102

Concord, Ontario, Canada

Bausch Site 103

Mississauga, Ontario, Canada

Bausch Site 105

Toronto, Ontario, Canada

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

Countries

Canada

References

Muzychuk A, Harasymowycz P. Efficacy and safety evaluation of a new full visual range vs monofocal intraocular lens in patients with cataract: randomized, controlled Canadian clinical trial. J Cataract Refract Surg. 2025 Oct 1;51(10):867-875. doi: 10.1097/j.jcrs.0000000000001714.

Reference Type: DERIVED

PMID: 40490939 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

900

Identifier Type: -

Identifier Source: org_study_id