← Back to Search

Monofocal Intraocular Lens

Monofocal Intraocular Lens for Cataracts (PRECISE Trial)

Hershey, PA
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
Drug Has Already Been Approved
No Placebo-Only Group

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

See full description
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.Check my eligibility
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.See study design
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.
 show original
Select...
My vision issues are only due to cataracts, and I'm expected to see well after surgery.
 show original
Select...
I have had both eyes implanted with a specific lens to correct my vision to near perfect.
 show original
Select...
My eyes are clear of any bleeding, except for cataracts.
 show original

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.
 show original
Select...
My pupils don't react normally to light changes.
 show original
Select...
I have eye conditions that could complicate cataract surgery.
 show original
Select...
I have vision loss that affects my ability to see clearly.
 show original
Select...
I had surgery complications preventing the implant of a CT LUCIA 621P IOL.
 show original
Select...
I have had eye surgery that could affect study results or increase my risk.
 show original
Select...
I have had eye surgery, but not for the retina or simple laser treatments.
 show original
Select...
I have a history of serious eye conditions like glaucoma or macular degeneration.
 show original

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.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Closest Location:Huffman & Huffman PSC· Lexington, KY· 158 miles

Who is running the clinical trial?

Carl Zeiss Meditec AGLead Sponsor
42 Previous Clinical Trials
7,713 Total Patients Enrolled
27 Trials studying Cataract
4,032 Patients Enrolled for Cataract
~25 spots leftby Mar 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top