Clinical Investigation of Expanded Designs of a Multifocal IOL

Cataract Clinical Trial

Official title:

Clinical Investigation of Expanded Designs of the Tecnis® Multifocal 1-Piece IOL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714635
• Other study ID #: DIOL-106-ZMLA
• Status: Completed
• Phase: Phase 1
• First received: October 24, 2012
• Last updated: February 26, 2015
• Start date: November 2012
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: July 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Tecnis Multifocal Intraocular Lens

• Monofocal Intraocular Lens

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean Diopter Range With VA of 20/40 or Better	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.	six months	No
Secondary	Spectacle Independence	Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.	six months	No