Investigation of the Safety and Effectiveness of a Trifocal IOL

Study Overview
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Brief Summary
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This study is a prospective, multicenter, randomized, double masked confirmatory trial comparing an investigational trifocal intraocular lens (IOL) and a commercially available monofocal IOL.

Detailed Description
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The study will include adult subjects with operable cataracts in both eyes who are eligible for phacoemulsification cataract surgery followed by IOL implantation.

Official Title
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Clinical Investigation of the Safety and Effectiveness of FINEVISION HP Trifocal IOL

Conditions
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Eye Diseases, Postcataract Aphakia, Cataract, Lens Opacities

Intervention / Treatment
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* Device: FINEVISION HP IOL
* Device: Alcon AcrySof SN60AT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female adults, age 22 years or older at the Preoperative Visit. Visually significant cataracts in both eyes that are eligible for phacoemulsification cataract surgery. Willing to undergo cataract surgery in the second operative eye within 7 - 30 days after surgery in the first eye. Projected BCDVA of 0.2 logMAR (20/32 Snellen) or better in each eye after cataract surgery/IOL implantation, as determined by the medical judgement of the Investigator Eligible for receipt of an IOL power within the range of the investigational IOL (+10.0 D to +30.0 D, in 0.50 D increments) in each eye Contact lens users must be willing to discontinue wear of their lenses in accordance with the following requirements: Rigid gas permeable lenses for ≥ 7 days prior to the Preoperative Visit Soft contact lenses for ≥ 3 days prior to the Preoperative Visit Contact lens wearers must demonstrate a stable refraction (within ±0.50 D for both sphere and cylinder) in each eye, as determined by manifest refraction on two consecutive examination dates at least one week apart after discontinuation of contact lens wear. Provide signed written consent prior to participation in any study-related procedures. Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits. Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at the Preoperative Visit. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence. Exclusion Criteria: History or presence of, or predisposition to, degenerative visual disorders (e.g., macular degeneration, retinal detachment, proliferative diabetic retinopathy, or other retinal disorders) predicted to result in BCDVA worse than 0.2 LogMAR (20/32 Snellen) in either eye during the study participation period. Significant anterior segment pathology in either eye that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome) Reasonably expected to require secondary ocular surgical intervention or laser treatment other than YAG capsulotomy in either eye during the study participation period. Presence of one or more clinically significant corneal abnormalities in either eye, including corneal dystrophy, irregularity, or edema per the Investigator's medical opinion. Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, LASIK, astigmatic keratotomy and limbal relaxing incisions in either eye Rubella, congenital, traumatic or complicated cataract in either eye Preoperative keratometric astigmatism > 1.0 D or irregular corneal astigmatism in either eye (Note: corneal incisions intended to reduce astigmatism are not permitted) Clinically significant ocular inflammation or infection present ≤ 30 days in either eye prior to the Preoperative Visit. Presence or history of one or more severe/serious ocular conditions (e.g., glaucoma, uveitis, ocular infection, severe dry eye) in either eye, or any other unstable medical condition (e.g., uncontrolled diabetes) that in the opinion of the Investigator would put the subject's health at risk, confound the results of the study and/or prevent the subject from completing all study visits. Use of medications known to interfere with visual performance, pupil dilation, or iris structure ≤ 30 days prior to the Preoperative Visit. Participation in any study of an investigational, interventional product within 30 days prior to the Preoperative Visit or at any time during the study period. Pregnant or nursing females.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Approximately 501 subjects will be screened across up to 24 study sites to complete 300 subjects implanted bilaterally with the FINEVISION HP and 150 subjects implanted bilaterally with the control monofocal Alcon AcrySof SN60AT.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FINEVISION HP<br>Trifocal FINEVISION HP. Cataractous lens will be removed in the study eyes and the FINEVISION HP will be implanted in the capsular bag. | Device: FINEVISION HP IOL<br>* Cataractous lens will be removed in the study eyes and the FINEVISION HP IOL will be implanted in the capsular bag.<br>|
| Active Comparator: Control Product<br>Cataractous lens will be removed in the study eyes and the Alcon AcrySof® SN60AT IOL will be implanted in the capsular bag. | Device: Alcon AcrySof SN60AT<br>* Cataractous lens will be removed in the study eyes and the Alcon AcrySof SN60AT IOL will be implanted in the capsular bag.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected distance visual acuity (BCDVA) in first operative eyes | Photopic monocular logMAR best corrected distance visual acuity (BCDVA) in first operative eyes at Month 6 (Visit 4) | 150-180 days after surgery on the first eye | 
| Distance corrected Near visual acuity (DCNVA) in first operative eyes | Photopic monocular logMAR distance corrected near visual acuity (DCNVA) in first operative eyes at Month 6 (Visit 4) | 150-180 days after surgery on the first eye | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance corrected Intermediate visual acuity at 66 cm in first operative eyes | Mean photopic monocular DCVA at intermediate (66 cm) for the first operative eye at Month 6 | 150-180 days after surgery on the first eye | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular Lens, Multifocal, Hydrophobic