Clinical trial NCT01714635: Clinical Investigation of Expanded Designs of a Multifocal IOL
Official title: Clinical Investigation of Expanded Designs of the Tecnis® Multifocal 1-Piece IOL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cataract
Keywords: cataract
IOL
intraocular lens
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2012-10-26
Enrollment: 445
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm
timeFrame: six months
Secondary outcomes:
measure: Mean Diopter Range With VA of 20/40 or Better
timeFrame: six months
measure: Spectacle Independence
timeFrame: six months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Fishkind, Bakewell & Maltzman Eye Care & Surgery Center
state: Arizona
city: Rogers
country: United States
facility: Boozman-Hof Regional Eye Clinic
state: Arkansas
city: Bakersfield
country: United States
facility: Empire Eye & Laser Center
state: California
city: Beverly Hills
country: United States
facility: Assil Eye Institute
state: California
city: Cape Coral
country: United States
facility: Cape Coral Eye Center (Argus Research Center)
state: Florida
city: Rock Island
country: United States
facility: Virdi Eye Clinic & Laser Vision Center
state: Illinois
city: Indianapolis
country: United States
facility: Eye Surgeons of Indiana
state: Indiana
city: Alexandria
country: United States
facility: Wallace Eye Surgery
state: Louisiana
city: Chesterfield
country: United States
facility: Pepose Vision Institute
state: Missouri
city: Rockville Center
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Allenwood
country: United States
facility: The Eye Center of Central PA
state: Pennsylvania
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Wilkes Barre
country: United States
facility: Bucci Cataract & Laser Vision
state: Pennsylvania
city: Goodlettsville
country: United States
facility: Loden Vision Center
state: Tennessee
city: Houston
country: United States
facility: Whitsett Vision Group
state: Texas
city: Sugar Land
country: United States
facility: Lone Star Eye Care
state: Texas
city: Lacey
country: United States
facility: Clarus Eye Centre
state: Washington
city: Solihull
country: United Kingdom
facility: The Midline Eye Institute
Study officials:
affiliation: Abbott Medical Optics
name: Kendra Hileman, PhD
role: STUDY_DIRECTOR
References: