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

Bausch & Lomb Incorporated1 site in 1 country27 target enrollmentAugust 15, 2024

ConditionsCataract

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataract
Sponsor: Bausch & Lomb Incorporated
Enrollment: 27
Locations: 1
Primary Endpoint: Photopic binocular distance corrected intermediate visual acuity (DCIVA) at 66 cm at post-operative visit 3
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 15, 2024

End Date

December 12, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bausch & Lomb Incorporated

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
•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.
•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.
•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.
•Subjects must have clear intraocular media other than the cataract in both eyes.
•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.
•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.
•Subjects must require an IOL power from +18.0 diopter (D) to +26.0 D in both eyes.
•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

•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.
•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.
•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 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.
•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 BCDVA 20/100 or worse in either eye.