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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects aged 22 years and older
Subjects willing to abstain from pursuing any other refractive surgery for the duration of the study
Must not have
Subjects who had a Nd:YAG capsulotomy less than 1 month prior to the planned IOPCL surgery
Subjects with pupil size abnormalities in mesopic conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test if the AccuraSee™ lens can make it easier to see things up close or at a medium distance after cataract surgery.
Who is the study for?
This trial is for individuals who have had cataract surgery but still struggle with near or intermediate vision. It's not specified, but typically participants should be in good general health and have stable vision post-surgery.
What is being tested?
The AccuraSee™ IOPCL, a lens implanted into the eye, is being tested to see if it can improve near and/or intermediate vision after someone has already had cataract surgery.
What are the potential side effects?
While specific side effects are not listed, similar eye implants may cause visual disturbances like glare or halos, discomfort or redness in the eye, increased eye pressure, or infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 22 years old or older.
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I agree not to have any eye surgery to correct my vision while in this study.
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I have had cataract surgery with a specific type of lens implant.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had a laser eye procedure less than 1 month ago.
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My pupils are not normal size in low light.
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I have an eye condition like retinal detachment or diabetic retinopathy.
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I had cataract surgery with a specific lens type that doesn't meet the study's requirements.
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I have eye conditions that could affect study results.
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I have had issues with eye pressure, glaucoma, or lazy eye.
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I had cataract surgery with a lens that is not monofocal.
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I have had laser eye surgery before.
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I have eye conditions like visible fundus, aniridia, optic nerve damage, or issues with my lens.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Improvement in uncorrected near visual acuity (UCNVA) at 40 cm/16 inches
Other study objectives
Endothelial Cell Counts
Improvement in uncorrected intermediate visual acuity (UCIVA) (at 66 cm/26 inches)
Intraocular Pseudophakic Capsular Lens (IOPCL) Long-term adherence and positional stability (tilt)
+6 moreAwards & Highlights
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: AccuraSee™ intraocular pseudophakic capsular lens (IOPCL)Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
OnPoint Vision IncLead Sponsor
2 Previous Clinical Trials
19 Total Patients Enrolled
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