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Monofocal Intraocular Lens

Monofocal Intraocular Lens for Cataracts (PRECISE Trial)

Phase 4
Recruiting
Research Sponsored by Carl Zeiss Meditec AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presenting for uncomplicated bilateral cataract surgery for age-related cataract
No visual acuity limiting pathologies other than cataract. Best corrected postoperative visual acuity potential of 20/25 or better in both eyes as estimated by potential acuity meter or surgeon estimation
Must not have
Planned monocular cataract extraction
Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three (3) months
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial aims to study how well a specific type of lens (CT LUCIA 621P IOL) works in improving vision for adults over 50 years old after cataract surgery over

Who is the study for?
This trial is for adults over 50 with age-related cataracts needing surgery in both eyes, without other eye conditions affecting vision. They must be able to follow the study's procedures and visits, have clear media besides cataract, and aim for a post-surgery vision of 20/25 or better.
What is being tested?
The study tests the CT LUCIA 621P IOL, a type of lens implanted after removing cataracts. It checks how well patients can see three months after getting this new lens during their routine cataract surgery.
What are the potential side effects?
Potential side effects are not specified here but generally may include discomfort, redness or swelling in the eye, increased risk of retinal detachment or endophthalmitis (eye infection), and visual disturbances like glare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having surgery for cataracts in both eyes due to aging.
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My vision issues are only due to cataracts, and I'm expected to see well after surgery.
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I have had both eyes implanted with a specific lens to correct my vision to near perfect.
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My eyes are clear of any bleeding, except for cataracts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am scheduled for cataract surgery in one eye.
Select...
My pupils don't react normally to light changes.
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I have eye conditions that could complicate cataract surgery.
Select...
I have vision loss that affects my ability to see clearly.
Select...
I had surgery complications preventing the implant of a CT LUCIA 621P IOL.
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I have had eye surgery that could affect study results or increase my risk.
Select...
I have had eye surgery, but not for the retina or simple laser treatments.
Select...
I have a history of serious eye conditions like glaucoma or macular degeneration.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three (3) months
This trial's timeline: 3 weeks for screening, Varies for treatment, and three (3) months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Monocular best corrected distance visual acuity (CDVA)
Secondary study objectives
Refractive Predictability
Refractive Stability

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bilateral implantation of investigational deviceExperimental Treatment1 Intervention
Monofocal IOL

Find a Location

Who is running the clinical trial?

Carl Zeiss Meditec AGLead Sponsor
42 Previous Clinical Trials
7,954 Total Patients Enrolled
~0 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
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