Clinical Evaluation of a 1-Piece Intraocular Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01098812
First received: March 31, 2010
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

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

Condition Intervention Phase
Cataract
Device: Tecnis ZCB00 IOL (control)
Device: Toric Intraocular lens
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the TECNIS® Toric 1-Piece Intraocular Lens

Resource links provided by NLM:


Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Mean Percent Reduction in Cylinder [ Time Frame: 6 months after second eye implant compared to baseline ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Uncorrected Distance Visual Acuity (UCDVA) [ Time Frame: 6 months after second eye implant ] [ Designated as safety issue: No ]
    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.


Enrollment: 269
Study Start Date: March 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098812

Locations
United States, California
AMO Clinical Research Call Center for Trial Locations
Santa Ana, California, United States, 92705
Sponsors and Collaborators
Abbott Medical Optics
Investigators
Study Director: Nicholas Tarantino, O.D. Abbott Medical Optics
  More Information

No publications provided

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01098812     History of Changes
Other Study ID Numbers: TIOL-103-TCNS
Study First Received: March 31, 2010
Results First Received: May 2, 2013
Last Updated: June 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Medical Optics:
Cataract, Intraocular lens

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 16, 2014