Clinical Investigation of the Next-Generation Intraocular Lens
NCT ID: NCT03111550
Last Updated: 2025-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
242 participants
INTERVENTIONAL
2017-05-10
2018-02-23
Brief Summary
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The study was conducted at 12 sites in the U.S.A and treated approximately 240 subjects, equally split between the two test groups and the control group.
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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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Investigational Lens Device #1
Investigational Intraocular Lens Device #1: Tecnis Model ZHR00
Investigational Intraocular Lens Device #1: TECNIS Model ZHR00
Intraocular lens replaces the natural lens removed during cataract surgery.
Investigational Lens Device #2
Investigational Intraocular Lens Device #2: Tecnis Model ZQR00
Investigational Intraocular Lens Device #2: TECNIS Model ZQR00
Intraocular lens replaces the natural lens removed during cataract surgery.
Control Device
Control TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00
TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00
Intraocular lens replaces the natural lens removed during cataract surgery.
Interventions
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Investigational Intraocular Lens Device #1: TECNIS Model ZHR00
Intraocular lens replaces the natural lens removed during cataract surgery.
Investigational Intraocular Lens Device #2: TECNIS Model ZQR00
Intraocular lens replaces the natural lens removed during cataract surgery.
TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00
Intraocular lens replaces the natural lens removed during cataract surgery.
Eligibility Criteria
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Inclusion Criteria
* Potential for postoperative BCDVA of 20/30 Snellen or better
* Corneal astigmatism of 1.00 D or less in both eyes
* Normal corneal topography
* Clear intraocular media other than cataract in each eye
* Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
Exclusion Criteria
* Irregular corneal astigmatism
* Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
* Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery
* Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study
* Inability to achieve keratometric stability for contact lens wearers
* Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
* Subjects with diagnosed degenerative visual disorders
* Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
* Use of systemic or ocular medications that may affect vision
* Prior, current, or anticipated use of tamsulosin or silodosin
* Poorly-controlled diabetes
* Acute, chronic, or uncontrolled systemic or ocular disease or illness
* Known ocular disease or pathology that may affect visual acuity or may require surgical intervention during the course of the study or may be expected to require retinal laser treatment or other surgical intervention during the course of the study
* Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
* Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial
* Desire for monovision correction
22 Years
ALL
No
Sponsors
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Abbott Medical Optics
INDUSTRY
Responsible Party
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Principal Investigators
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Devi Priya Janakiraman, OD,FAAO
Role: STUDY_DIRECTOR
Abbott Medical Optics
Locations
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Empire Eye and Laser Center
Bakersfield, California, United States
Assil Eye Institute
Beverly Hills, California, United States
Jones Eye Care
Sioux City, Iowa, United States
Chesapeake Eye Care and Laser
Annapolis, Maryland, United States
Eye Doctors of Washington
Chevy Chase, Maryland, United States
Ophthalmology Consultants LTD
St Louis, Missouri, United States
Scott and Christie and Associates,PC
Cranberry Township, Pennsylvania, United States
Carolina Cataract and Laser Center
Ladson, South Carolina, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Loden Vision Centers
Goodlettsville, Tennessee, United States
Key-Whitman Eye Center
Dallas, Texas, United States
Texas Eye and Laser Center
Hurst, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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EDOF-121-NGPC
Identifier Type: -
Identifier Source: org_study_id
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