Clinical Investigation of Expanded Designs of a Multifocal IOL

Phase 1

Completed

Conditions: Cataract

Interventions: Device: Tecnis Multifocal Intraocular Lens
Device: Monofocal Intraocular Lens

Registration Number: NCT01714635

Lead Sponsor: Abbott Medical Optics

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 445

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tecnis Multifocal Intraocular lens #1	Tecnis Multifocal Intraocular Lens	A low diopter add multifocal intraocular lens
Tecnis Multifocal Intraocular Lens #2	Tecnis Multifocal Intraocular Lens	A low diopter add multifocal intraocular lens
Monofocal Intraocular Lens	Monofocal Intraocular Lens	Commercially available monofocal intraocular lens (IOL)

Primary Outcome Measures

Name	Time	Method
Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm	six months	Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative

Secondary Outcome Measures

Name	Time	Method
Mean Diopter Range With VA of 20/40 or Better	six months	Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately\) to reach the 6-month visit were included in the substudy. \ The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively.
Spectacle Independence	six months	Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.

Trial Locations

Locations (18): The Eye Center of Central PA
🇺🇸
Allenwood, Pennsylvania, United States
The Midline Eye Institute
🇬🇧
Solihull, United Kingdom
Eye Surgeons of Indiana
🇺🇸
Indianapolis, Indiana, United States
Ophthalmic Consultants of Long Island
🇺🇸
Rockville Center, New York, United States
Bucci Cataract & Laser Vision
🇺🇸
Wilkes Barre, Pennsylvania, United States
Lone Star Eye Care
🇺🇸
Sugar Land, Texas, United States
Assil Eye Institute
🇺🇸
Beverly Hills, California, United States
Virdi Eye Clinic & Laser Vision Center
🇺🇸
Rock Island, Illinois, United States
Pepose Vision Institute
🇺🇸
Chesterfield, Missouri, United States
Scott & Christie and Associates, PC
🇺🇸
Cranberry Township, Pennsylvania, United States
Fishkind, Bakewell & Maltzman Eye Care & Surgery Center
🇺🇸
Tucson, Arizona, United States
Loden Vision Center
🇺🇸
Goodlettsville, Tennessee, United States
Whitsett Vision Group
🇺🇸
Houston, Texas, United States
Cape Coral Eye Center (Argus Research Center)
🇺🇸
Cape Coral, Florida, United States
Clarus Eye Centre
🇺🇸
Lacey, Washington, United States
Boozman-Hof Regional Eye Clinic
🇺🇸
Rogers, Arkansas, United States
Empire Eye & Laser Center
🇺🇸
Bakersfield, California, United States
Wallace Eye Surgery
🇺🇸
Alexandria, Louisiana, United States