Clinical Evaluation of a 1-Piece Intraocular Lens

Clinical Evaluation of the TECNIS® Toric 1-Piece Intraocular Lens

The aims of this study are to:

• Demonstrate a reduction in postoperative cylinder compared to results from the control lens
• Demonstrate better uncorrected distance visual acuity compared to the control lens

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Tecnis ZCB00 IOL (control); Device: Toric Intraocular lens

• Study Type: Interventional
• Enrollment (Actual): 269
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Ana, California, United States, 92705
      • AMO Clinical Research Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Minimum 18 years of age
• Cataract for which phacoemulsification extraction and posterior chamber IOL implantation has been planned for both eyes
• Preoperative best corrected distance visual acuity (BCDVA)of 20/40 or worse (Snellen), with or without glare, for each eye
• BCDVA projected to be better than 20/30 following cataract removal and IOL implantation for each eye
• Preoperative keratometric cylinder of 0.75 diopters to 3.62 diopters for each eye (with exception of second eyes with 0.0-0.75 diopters planned to receive non-toric IOL)
• Clear intraocular media other than cataract in both eyes
• Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
• Signed informed consent and HIPAA authorization

Exclusion Criteria:

• Requiring IOLs outside spherical power range of +15.0 to +28.0 diopters
• Dilated pupil size less than 5.5 mm or the presence of any pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)in either eye
• Previous corneal or intraocular surgery in either eye
• Irregular corneal astigmatism in either eye
• Corneal pathology/abnormality potentially affecting topography in either eye
• Corneal abnormalities such as stromal, epithelial or endothelial dystrophies in either eye
• Inability to achieve keratometric stability in either eye for contact lens wearers
• Subjects with diagnosed degenerative visual disorders in either eye(eg., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse
• 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
• An eccentric anterior capsulorhexis, zonular damage/rupture or capsular tear/rupture during the cataract extraction procedure
• Use of systemic or ocular medications that may affect vision
• Prior, current, or anticipated use during the course of the nine month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo)likely to affect dilation or iris structure
• Poorly-controlled diabetes
• Acute, chronic, or uncontrolled systemic disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.)
• Uncontrolled ocular hypertension or glaucomatous changes in the retina or visual field in either eye
• Known ocular disease or pathology that may affect visual acuity or that may require 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 during 30 days prior to preoperative visit in any other clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control IOL; Approved Intraocular control lens	Device: Tecnis ZCB00 IOL (control); Tecnis 1-piece acrylic IOL
Experimental: Toric IOL; Investigational Toric IOL	Device: Toric Intraocular lens; Toric acrylic intraocular lens with various cylinder powers
Experimental: Higher Cylinder Toric IOL; Investigational Toric IOLs with higher cylinder powers.	Device: Toric Intraocular lens; Toric acrylic intraocular lens with various cylinder powers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Reduction in Cylinder	Reduction in cylinder postoperatively vs. preoperatively (baseline) as measured by keratometry and manifest refraction. Mean percent reduction in cylinder = (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder). Reduction in cylinder was assessed in the first eye (per participant) for contribution to the mean.	6 months after second eye implant compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected Distance Visual Acuity (UCDVA)	Postoperative uncorrected distance visual acuity as measured by LogMAR acuity. For comparison: LogMAR value of 0.0 = Snellen 20/20; LogMar 0.10 = Snellen 20/25; LogMAR 0.20 = Snellen 20/32; LogMAR 0.30 = Snellen 20/40. Uncorrected distance visual acuity as measured by LogMAR acuity was assessed in the first eye (per participant) for contribution to the mean.	6 months after second eye implant

Collaborators and Investigators

• Sponsor: Abbott Medical Optics
• Investigators: Study Director: Nicholas Tarantino, O.D., Abbott Medical Optics

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: March 31, 2010
• First Submitted That Met QC Criteria: April 2, 2010
• First Posted (Estimated): April 5, 2010

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Cataract, Intraocular lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: TIOL-103-TCNS