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

NCT06479148 | Terminated FDA Device

• 1 other identifier: 927
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

enVista® Aspire ™

EXPERIMENTAL

Device: enVista® Aspire™

An IOL with a slightly extended depth of focus

ACTIVE COMPARATOR

Device: An IOL with a slightly extended depth of focus

enVista® Monofocal IOL (MX60E)

OTHER

Other

Device: MX60E

Interventions

enVista® Aspire™ DEVICE

Eyes will receive enVista® Aspire™ lenses

enVista® Aspire ™

An IOL with a slightly extended depth of focus DEVICE

Eyes will receive lenses with a slightly extended depth of focus

An IOL with a slightly extended depth of focus

MX60E DEVICE

Eyes will receive MX60E lenses

enVista® Monofocal IOL (MX60E)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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 within 30 days prior to enrollment.
• 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).
• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Site 101 Centro Oftalmológico Robles

Santa Rosa de Copán, Copán Department, 41101, Honduras

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

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: June 24, 2024
• First Posted: June 28, 2024
• Study Start: August 15, 2024
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HO (1)