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Intraocular Lens

Intraocular Lenses for Cataracts

South Orange, NJ

N/A

Recruiting

Research Sponsored by Bausch & Lomb Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

22 years of age or older on the date the Informed Consent Form (ICF) is signed

Have a BCDVA at or worse than 20/40 in each eye, with or without a glare source, due to a clinically significant cataract that is considered amenable to treatment with standard phacoemulsification cataract extraction and capsular IOL implantation

Must not have

Pre-existing ocular conditions such as prior corneal refractive surgery, irregular corneal astigmatism, severe corneal dystrophy, macular disease, optic nerve atrophy, corneal endothelial disease, abnormal cornea, macular degeneration, retinal degeneration, chronic drug miosis, etc.

Rubella, congenital, traumatic, or complicated cataracts

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at postop visit 1 (day 14 to 42 days after second eye iol implantation)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to assess how well the enVista Aspire and Aspire Toric intraocular lens models work in real-life situations and how satisfied surgeons and patients are with them.

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Who is the study for?

This trial is for individuals undergoing cataract extraction who are suitable candidates for intraocular lens implantation. Specific eligibility criteria details were not provided, so it's best to consult the study team or your doctor.Check my eligibility

What is being tested?

The study is testing two types of lenses: enVista Aspire (EA) and Aspire Toric (ETA), which are implanted during cataract surgery. The goal is to assess how well these lenses perform in real-world conditions and patient satisfaction with the results.See study design

What are the potential side effects?

While specific side effects aren't listed, common risks associated with intraocular lens implants include inflammation, infection, bleeding, swelling, detachment of retina, glaucoma and sometimes a secondary cataract.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 22 years old or older.

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My vision is 20/40 or worse in both eyes due to cataracts treatable with standard surgery.

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My eyes are healthy except for cataracts.

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I need a toric lens for my eye surgery due to significant astigmatism between 1.25D and 5.75D.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of serious eye conditions.

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I have cataracts due to rubella, birth defects, injury, or complications.

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I have a history or risk of serious eye conditions, including retinal detachment.

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I have aniridia.

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My eye's front chamber is very shallow, not because of a swollen cataract.

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I have recurring eye inflammation with an unknown cause.

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I have glaucoma that is not well-managed.

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I need a procedure to widen my pupil.

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I have significant loss of the gel-like substance inside my eye.

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I have abnormal blood vessel growth in my eye.

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I have significant bleeding in the front part of my eye.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at postop visit 1 (day 14 to 42 days after second eye iol implantation)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at postop visit 1 (day 14 to 42 days after second eye iol implantation)

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at postop visit 1 (day 14 to 42 days after second eye iol implantation) for reporting.