Clinical Investigation of Expanded Designs of a Multifocal IOL

NCT01714635 | Completed Phase 1 Results

• 1 other identifier: DIOL-106-ZMLA
• Study Type: interventional
• Target: 445
• Locations: 2 countries
• Sites: 18

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.

Conditions

Cataract

Keywords

cataract; IOL; intraocular lens

Outcome Measures

Primary Outcomes (1)

• Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm

  Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative

  six months

Secondary Outcomes (2)

• Mean Diopter Range With VA of 20/40 or Better

  six months

• Spectacle Independence

  six months

Study Arms (3)

Tecnis Multifocal Intraocular lens #1

EXPERIMENTAL

A low diopter add multifocal intraocular lens

Device: Tecnis Multifocal Intraocular Lens

Tecnis Multifocal Intraocular Lens #2

EXPERIMENTAL

A low diopter add multifocal intraocular lens

Device: Tecnis Multifocal Intraocular Lens

Monofocal Intraocular Lens

ACTIVE COMPARATOR

Commercially available monofocal intraocular lens (IOL)

Device: Monofocal Intraocular Lens

Interventions

Tecnis Multifocal Intraocular Lens DEVICE

Tecnis Multifocal Intraocular Lens #2; Tecnis Multifocal Intraocular lens #1

Monofocal Intraocular Lens DEVICE

Monofocal Intraocular Lens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Abbott Medical Optics: lead

Study Sites (18)

Fishkind, Bakewell & Maltzman Eye Care & Surgery Center

Tucson, Arizona, 85704, United States

Location

Boozman-Hof Regional Eye Clinic

Rogers, Arkansas, 72757, United States

Location

Empire Eye & Laser Center

Bakersfield, California, 93309, United States

Location

Assil Eye Institute

Beverly Hills, California, 90210, United States

Location

Cape Coral Eye Center (Argus Research Center)

Cape Coral, Florida, 33904, United States

Location

Virdi Eye Clinic & Laser Vision Center

Rock Island, Illinois, 61201, United States

Location

Eye Surgeons of Indiana

Indianapolis, Indiana, 46256, United States

Location

Wallace Eye Surgery

Alexandria, Louisiana, 71303, United States

Location

Pepose Vision Institute

Chesterfield, Missouri, 63017, United States

Location

Ophthalmic Consultants of Long Island

Rockville Centre, New York, 11570, United States

Location

The Eye Center of Central PA

Allenwood, Pennsylvania, 17810, United States

Location

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, 16066, United States

Location

Bucci Cataract & Laser Vision

Wilkes-Barre, Pennsylvania, 18702, United States

Location

Loden Vision Center

Goodlettsville, Tennessee, 37072, United States

Location

Whitsett Vision Group

Houston, Texas, 77055, United States

Location

Lone Star Eye Care

Sugar Land, Texas, 77479, United States

Location

Clarus Eye Centre

Lacey, Washington, 98503, United States

Location

The Midline Eye Institute

Solihull, B91 2AW, United Kingdom

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Kendra Hileman, Ph.D., Director, Clinical Research & Development
• Organization: Abbott Medical Optics

kendra.hileman@amo.abbott.com

714-247-8613

Study Officials

• Kendra Hileman, PhD

  Abbott Medical Optics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: October 26, 2012
• Study Start: November 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: July 1, 2014
• Last Updated: March 17, 2015
• Results First Posted: January 15, 2015

Record last verified: 2014-11

Locations

GB (1); US (17)