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Intraocular Lens

Clareon Toric IOL for Astigmatism

N/A
Recruiting
Research Sponsored by Alcon Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Astigmatism in the operative eye(s)
Cataract in one or both eyes with planned extraction by conventional phacoemulsification
Must not have
History of retinal detachment, age-related macular degeneration, glaucoma, diabetic retinopathy, or any pathologic changes associated with the optic nerve
History of prior intraocular or corneal surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 1 to month 3, month 3 to month 6, month 6 to year 1, year 1 to year 3 (post implantation)
Awards & highlights

Summary

"This trial aims to study the safety and effectiveness of Clareon Toric Intraocular Lenses over a long period of time after they have been approved for use."

Who is the study for?
This trial is for individuals with cataracts and astigmatism who need their cataracts removed by standard surgery. Participants must be able to understand and sign a consent form, have no major eye diseases like glaucoma or macular degeneration, not be pregnant or nursing, and commit to all study visits.
What is being tested?
The study is evaluating the long-term safety and effectiveness of Clareon Toric Intraocular Lenses (IOLs) when used in patients undergoing cataract surgery to correct vision problems caused by astigmatism.
What are the potential side effects?
While specific side effects are not listed here, typical risks associated with intraocular lenses include inflammation, infection, lens dislocation, retinal detachment, visual disturbances such as glare or halos around lights. Cataract surgery itself may also carry additional risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have astigmatism in the eye(s) that will be operated on.
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I have a cataract(s) and plan to have it removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had eye problems like retinal detachment or glaucoma.
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I have had eye surgery before.
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I am pregnant, nursing, or might become pregnant during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1 to month 3, month 3 to month 6, month 6 to year 1, year 1 to year 3 (post implantation)
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 1 to month 3, month 3 to month 6, month 6 to year 1, year 1 to year 3 (post implantation) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean monocular best corrected distance visual acuity (BCDVA)
Secondary outcome measures
Mean absolute IOL rotation from end of surgery supine baseline to each subsequent visit
Mean absolute IOL rotation from previous visit
Mean monocular absolute residual refractive cylinder

Trial Design

1Treatment groups
Experimental Treatment
Group I: Clareon Toric IOLExperimental Treatment2 Interventions
Clareon Toric IOL implanted in one or both eyes during cataract surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cataract surgery
2015
N/A
~3790
Clareon Toric IOL
2022
N/A
~190

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Who is running the clinical trial?

Alcon ResearchLead Sponsor
726 Previous Clinical Trials
128,385 Total Patients Enrolled
19 Trials studying Aphakia
6,145 Patients Enrolled for Aphakia
Clinical Trial Management Operations, SurgicalStudy DirectorAlcon Research, LLC
1 Previous Clinical Trials
210 Total Patients Enrolled
1 Trials studying Aphakia
210 Patients Enrolled for Aphakia
~67 spots leftby May 2028
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