Study Results
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View full resultsBasic Information
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COMPLETED
NA
87 participants
INTERVENTIONAL
2024-06-18
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CPO Pro IOL
CPO Pro IOL implanted in the first eye, as randomized. The fellow eye will receive CPO IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery.
CPO Pro IOL
Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining comparable distance visual acuity.
CPO IOL
Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining distance visual acuity.
Cataract surgery
Extraction of the cataractous lens by phacoemulsification, followed by implantation of the IOL.
CPO IOL
CPO IOL implanted in the first eye, as randomized. The fellow eye will receive CPO Pro IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery.
CPO Pro IOL
Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining comparable distance visual acuity.
CPO IOL
Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining distance visual acuity.
Cataract surgery
Extraction of the cataractous lens by phacoemulsification, followed by implantation of the IOL.
Interventions
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CPO Pro IOL
Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining comparable distance visual acuity.
CPO IOL
Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining distance visual acuity.
Cataract surgery
Extraction of the cataractous lens by phacoemulsification, followed by implantation of the IOL.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to attend all scheduled study visits as required by the protocol;
* Planned cataract surgery (both eyes);
* Preoperative corneal astigmatism less that 1.00 diopter in each eye.
Exclusion Criteria
* Ocular conditions as specified in the protocol;
* Subjects who desire monovision correction.
22 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Principal Clinical Trial Lead, Surgical
Role: STUDY_DIRECTOR
Alcon Research, LLC
Locations
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Wolstan & Goldberg Eye Associates
Torrance, California, United States
Grosinger, Spigelman & Grey Eye Surgeons, P.C.
Bloomfield Hills, Michigan, United States
Moyes Eye Center
Kansas City, Missouri, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Carolina Eyecare Physicians, LLC
Mt. Pleasant, South Carolina, United States
Vision for Life
Nashville, Tennessee, United States
Houston Eye Associates
Houston, Texas, United States
The Eye Institute of Utah
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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ILQ137-C002-A
Identifier Type: -
Identifier Source: org_study_id
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