Clinical Evaluation of the Performance of the enVista® Aspire™ (EA) Lens

A Prospective, Single-Center, Randomized Clinical Investigation to Evaluate the Performance of enVista® Aspire ™ (EA) Intraocular Lens Against a Control and an Active-Comparator in Subjects Undergoing Cataract Extraction and Implantation of an Intraocular Lens

A Prospective, Single-Center, Randomized Clinical Investigation to evaluate the safety and performance of the enVista® Aspire ™ (EA) intraocular lens (IOL) when compared to the MX60E monofocal IOL (control lens) and an IOL with a slightly extended depth of focus (active comparator lens) for potentially improved optical properties.

Study Overview

• Status: Terminated
• Conditions: Cataract
• Intervention / Treatment: Device: enVista® Aspire™; Device: An IOL with a slightly extended depth of focus; Device: MX60E

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Honduras
  • Copán Department
    • Santa Rosa de Copán, Copán Department, Honduras, 41101
      • Site 101 Centro Oftalmológico Robles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
2. Subjects must have the capability to understand and provide 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.
3. Subjects must have a Best-corrected Distance Visual Acuity (BCDVA) worse than 20/40 in each 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.
4. Subjects must have a BCDVA projected to be better than 20/32 after IOL implantation in each eye as determined by the medical judgment of the Principal Investigator.
5. Subjects must have clear intraocular media other than the cataract in both eyes.
6. Have discontinued use of contact lenses for at least 2 weeks (for hard or toric lenses) or 3 days (for soft contact lenses) prior to the pre-operative examination, and through the day of surgery and must be willing to refrain from use of contact lenses throughout the clinical investigation.
7. 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 at least one week apart after discontinuation of contact lens wear.
8. Subjects must require an IOL power from +18.0 diopter (D) to +26.0 D in both eyes.
9. Subjects must be willing and able to comply with all treatment and follow-up Clinical Investigation visits and procedures, and to undergo second eye surgery on the same day as the first eye surgery. Illiterate subjects must be able to identify letters as required for the assessments.

Exclusion Criteria:

1. Subjects who have used an investigational drug or device within 30 days prior to screening visit and/or will participate in another investigation during the period of Clinical Investigation participation.
2. Subjects who have any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in either eye. Stable pterygium that minimally encroaches on the corneal surface is allowed.
3. 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.
4. Subjects who have uncontrolled glaucoma in either eye.
5. Subjects who have previous retinal detachment or clinically significant retinal pathology involving the macula in either eye.
6. Subjects who have proliferative or non-proliferative diabetic retinopathy in either eye.
7. Subjects who have a congenital ocular anomaly (e.g., aniridia, congenital cataract) in either eye.
8. 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 Clinical Investigation.
9. Subjects who have a history of chronic or recurrent inflammatory eye disease (e.g., iritis, scleritis, iridocyclitis, or rubeosis iridis) in either eye.
10. Subjects who have a visual disorder, other than cataracts, that could potentially cause future acuity losses to a level of BCDVA 20/100 or worse in either eye.
11. Subjects who have had previous intraocular or corneal surgery in either eye, with the exception of laser trabeculoplasty.
12. Subjects with any preoperative infectious conjunctivitis, keratitis, or uveitis in either eye within 30 days prior to enrollment.
13. Subjects who have a preoperative corneal astigmatism ≥ 2.0 D in either eye as confirmed by Corneal Topography, irregular astigmatism, or skewed radial axis (note: corneal incisions intended specifically to reduce astigmatism are not allowed during the Clinical Investigation).
14. Subjects who cannot achieve a minimum pharmacologic pupil dilation of 5.0 mm in both eyes.
15. Subjects who may be expected to require a combined or other secondary surgical procedure in either eye.
16. Subjects who during the first cataract extraction experience an anterior or posterior capsule tear or rupture, zonular dialysis, significant iris trauma, or other complication that may cause untoward effects in the judgment of the Principal Investigator.
17. Females of childbearing potential (those who are not surgically sterilized or at least 12 months postmenopausal) are excluded from enrollment in the Clinical Investigation if they are currently pregnant or plan to become pregnant during the Clinical Investigation. Females of childbearing potential must be willing to practice effective contraception for the duration of the Clinical Investigation.
18. Subjects with any other serious ocular pathology or underlying systemic medical condition (e.g., uncontrolled diabetes) or circumstance that, based on the Principal Investigator's judgment, poses a concern for the subjects' safety or could confound the results of the Clinical Investigation.
19. Subjects who have current or previous usage of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1A adrenoceptor (e.g., Flomax® (tamsulosin hydrochloride (HCl)), Terazosin, or Cardura).
20. Subjects with abnormal pupillary dilation dynamics (as determined by the medical judgment of the Principal Investigator) or eccentric or ectopic pupils in either eye.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: enVista® Aspire ™	Device: enVista® Aspire™; Eyes will receive enVista® Aspire™ lenses
Active Comparator: An IOL with a slightly extended depth of focus	Device: An IOL with a slightly extended depth of focus; Eyes will receive lenses with a slightly extended depth of focus
Other: enVista® Monofocal IOL (MX60E); Other	Device: MX60E; Eyes will receive MX60E lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photopic Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm at Post-operative Visit 3	Photopic binocular distance corrected intermediate visual acuity (DCIVA) at 66 cm at post-operative visit 3	Assessed from Day 90 to Day 150

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2024
• Primary Completion (Actual): December 12, 2024
• Study Completion (Actual): December 12, 2024

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 927

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes