Clinical Investigation of Expanded Designs of a Multifocal IOL

Completed · Phase 1

Conditions studied: Cataract

In brief

The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide statistically better distance-corrected near visual acuity compared to the monofocal control lens. Complication and adverse event rates associated with each Multifocal IOL will be within the ISO SPE rate for posterior chamber IOLs.

Key facts

Study ID

NCT01714635

Run by

Abbott Medical Optics

People needed

445

Starts

2012-11-01

Expected to finish

2014-07-01

Last updated by the study team

2015-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Minimum 18 years of age
• Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
• Preoperative best-corrected distance visual acuity (BCDVA) of 20/40 or worse (Snellen) with or without a glare source
• Potential for postoperative best-corrected visual acuity of 20/25 or better
• Preoperative corneal astigmatism of 1.0 D or less with normal corneal topography and no irregular corneal astigmatism
• Clear intraocular media, other than cataract
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
• Ability to understand and respond to a questionnaire verbally administered in English

You may not qualify if…

• Requiring an intraocular lens power outside the available range of +16.0 to +28.0 D
• Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
• Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes
• Prior 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 of 20/30 or worse during the study
• Inability to achieve keratometric stability for contact lens wearers
• Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study
• Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects
• Use of systemic or ocular medications that may affect vision
• Prior, current, or anticipated use during the course of the 12-month study of tamsulosin or silodosin (e.g., Flomax®, Flomaxtra®, Rapaflo®) likely, in the opinion of the investigator, to cause poor dilation or lack of adequate iris structure to perform standard cataract surgery
• Inability to focus, fixate or maintain binocular vision for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
• Poorly-controlled diabetes
• Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: ocular hypertension without glaucomatous changes is acceptable.
• Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
• 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 30 days prior to preoperative visit in any other clinical trial
• Desire for monovision correction

Where it is running

• Fishkind, Bakewell & Maltzman Eye Care & Surgery Center — Tucson, Arizona, United States
• Boozman-Hof Regional Eye Clinic — Rogers, Arkansas, United States
• Empire Eye & Laser Center — Bakersfield, California, United States
• Assil Eye Institute — Beverly Hills, California, United States
• Cape Coral Eye Center (Argus Research Center) — Cape Coral, Florida, United States
• Virdi Eye Clinic & Laser Vision Center — Rock Island, Illinois, United States
• Eye Surgeons of Indiana — Indianapolis, Indiana, United States
• Wallace Eye Surgery — Alexandria, Louisiana, United States
• Pepose Vision Institute — Chesterfield, Missouri, United States
• Ophthalmic Consultants of Long Island — Rockville Centre, New York, United States
• The Eye Center of Central PA — Allenwood, Pennsylvania, United States
• Scott & Christie and Associates, PC — Cranberry Township, Pennsylvania, United States
• Bucci Cataract & Laser Vision — Wilkes-Barre, Pennsylvania, United States
• Loden Vision Center — Goodlettsville, Tennessee, United States
• Whitsett Vision Group — Houston, Texas, United States
• Lone Star Eye Care — Sugar Land, Texas, United States
• Clarus Eye Centre — Lacey, Washington, United States
• The Midline Eye Institute — Solihull, United Kingdom

Full record on ClinicalTrials.gov

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