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

NCT04224155 | Completed Results FDA Device

• 1 other identifier: 900
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 9

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

Outcome Measures

Primary Outcomes (5)

• Serious Adverse Events

  All serious adverse events 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 (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.

  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

• 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.

  Day 120 to Day 180 after second eye IOL implantation

Secondary Outcomes (6)

• Incidence of Subjects Experiencing at Least One Severe Visual Disturbance

  Day 120 to Day 180 after second eye IOL implantation

• Photopic Contrast Sensitivity With Glare at Post-Operative Visit 4

  Day 120 to Day 180 after second eye IOL implantation

• Mesopic Contrast Sensitivity With Glare at Post-Operative Visit 4

  Day 120 to Day 180 after second eye IOL implantation

• Mesopic Contrast Sensitivity Without Glare at Post-Operative Visit 4

  Day 120 to Day 180 after second eye IOL implantation

• IOL Rotation for All Eyes at Post-Operative Visit 4

  Day 120 to Day 180 after second eye IOL implantation

Study Arms (2)

enVista MX60EFH trifocal intraocular lens (IOL)

EXPERIMENTAL

Device: enVista MX60EFH trifocal intraocular lenses (IOLs)

enVista MX60E monofocal intraocular lens (IOL)

ACTIVE COMPARATOR

Device: enVista MX60E monofocal intraocular lenses (IOLs)

Interventions

enVista MX60EFH trifocal intraocular lenses (IOLs) DEVICE

enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally

enVista MX60EFH trifocal intraocular lens (IOL)

enVista MX60E monofocal intraocular lenses (IOLs) DEVICE

enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally

enVista MX60E monofocal intraocular lens (IOL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (9)

Bausch Site 106

Calgary, Alberta, Canada

Location

Bausch Site 102

Concord, Ontario, L4K 2Z5, Canada

Location

Bausch Site 103

Mississauga, Ontario, L6H 0J8, Canada

Location

Bausch Site 105

Toronto, Ontario, Canada

Location

Bausch Site 107

Toronto, Ontario, Canada

Location

Bausch Site 108

Vaughan, Ontario, Canada

Location

Bausch Site 101

Boisbriand, Quebec, J7H 0E8, Canada

Location

Bausch Site 113

Longueuil, Quebec, Canada

Location

Bausch Site 104

Montreal, Quebec, Canada

Location

Related Publications (1)

• 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.

  PMID: 40490939 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Johnson Varughese
• Organization: Bausch & Lomb

johnson.varughese@bausch.com

9089271162

Study Officials

• Anya Loncaric

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: March 10, 2020
• Primary Completion: June 14, 2022
• Study Completion: June 14, 2022
• Last Updated: October 10, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-02

Locations

CA (9)