A Study to Evaluate Real World Outcomes of the enVista® Aspire (EA) and Aspire Toric (ETA) Intraocular Lens in Subjects Undergoing Cataract Extraction

Bausch + Lomb

Status

Completed

Conditions

Cataract

Treatments

Device: enVista Aspire EA or Aspire Toric ETA IOLs

Study type

Interventional

Funder types

Industry

Identifiers

NCT06594185

BL-SU01-ASRWE-4401

Details and patient eligibility

About

A study to evaluate the real-world clinical performance of the enVista Aspire and Aspire Toric intraocular lens (IOL) models EA and ETA and to assess surgeon and subject satisfaction

Enrollment

335 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

22 years of age or older on the date the Informed Consent Form (ICF) is signed.
Subjects must be capable of understanding and providing informed consent on the Institutional Review Board (IRB)- approved Informed Consent Form (ICF) and authorization as appropriate for local privacy regulations.
Have a BCDVA at or 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.
Have a BCDVA projected to be better than 20/30 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.
Subjects must require an IOL power from +6.0 diopter (D) to +34.0 diopter (D) in both eyes.
Subjects with clinically significant preoperative corneal astigmatism must require an IOL toric power between 1.25 diopter (D) to 5.75 diopter (D).
Subjects must be willing and able to comply with all treatment and follow-up Clinical Investigation visits and procedures

Exclusion criteria

Pre-existing ocular conditions (subjects with prior corneal refractive surgery, irregular corneal astigmatism, severe (clinically significant) corneal dystrophy, e.g., Fuch's, macular disease, optic nerve atrophy, corneal endothelial disease, abnormal cornea, macular degeneration, retinal degeneration, and chronic drug miosis, who may not achieve the visual acuity of patients without such problems, etc.)
Associated ocular conditions that could affect the stability of the IOL (e.g., traumaticzonulolysis, zonular dialysis, evident zonular weakness or dehiscence, etc.) in the study eye.
Retinal conditions, or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or proliferative diabetic retinopathy, in which future treatment may be compromised by implanting this IOL
Amblyopia
Rubella, congenital, traumatic, or complicated cataracts
Extremely shallow anterior chamber, not due to swollen cataract
Recurrent anterior or posterior segment inflammation of unknown etiology, or any disease producing an inflammatory reaction (e.g., iritis or uveitis)
Aniridia
Iris neovascularization
Subjects who have uncontrolled glaucoma in either eye. Uncontrolled glaucoma is defined as intraocular pressure (IOP) greater than 21 mm Hg in spite of maximally tolerated medications (with more than three topical drugs for IOP control).
Microphthalmos or macrophthalmos
Previous corneal transplant, prior YAG laser iridotomy, YAG vitreolysis, and prior phakic IOL insertions.
Pre-existing ocular conditions that may negatively impact the stability of the implant or intraoperative conditions (posterior capsular rupture, complications in which the IOL stability could be compromised, inability to place IOL in capsular bag, etc.).
Mechanical or surgical manipulation required to enlarge the pupil
Vitreous loss (significant)
Anterior chamber bleeding (significant)