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Post-Approval Study of the Tecnis® Toric IOL

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ClinicalTrials.gov Identifier: NCT02566083
Recruitment Status : Active, not recruiting
First Posted : October 1, 2015
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Brief Summary:
Post-approval study to evaluate the rates of visual distortions for patients requiring >2.0 D of corneal astigmatism correction

Condition or disease Intervention/treatment Phase
Cataract Device: non-toric intraocular lens Device: toric intraocular lens Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 427 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-Approval Study of the Tecnis® Toric IOL, Models ZCT300 and ZCT400
Actual Study Start Date : October 21, 2015
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Arm Intervention/treatment
Active Comparator: non-toric intraocular lens
non-toric approved intraocular lens
Device: non-toric intraocular lens
TECNIS One-piece Monofocal Model ZCB00

Active Comparator: toric intraocular lens
approved toric intraocular lens
Device: toric intraocular lens
TECNIS One-piece Toric Models ZCT300 or ZCT400




Primary Outcome Measures :
  1. Rate of severe visual distortions [ Time Frame: 6 Months ]
    Rate of visual distortions based on data collected from a self-administered subject questionnaire


Secondary Outcome Measures :
  1. Rate of IOL repositioning procedures due to IOL misalignment [ Time Frame: 1 Year ]
    repositioning due to intraocular lens (IOL) mis-alignment


Other Outcome Measures:
  1. Rate of other adverse events [ Time Frame: 1 Year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Minimum 22 years of age
  • Bilateral cataracts
  • Preoperative keratometric cylinder in both eyes
  • Most appropriate toric IOL model choice (ZCT300 or ZCT400)
  • Predicted residual refractive cylinder, based on the AMO Toric IOL Calculator, must be:

    ≤ 0.69 D for a ZCT300 IOL or ≤ 0.88 D for a ZCT400 IOL

  • Clear intraocular media other than cataract in each eye
  • Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
  • Ability to understand, read and write English in order to consent to study participation and complete a study questionnaire
  • Signed informed consent and HIPAA authorization

Exclusion Criteria:

  • Irregular corneal astigmatism
  • Any corneal pathology/abnormality other than regular corneal astigmatism
  • Previous corneal surgery
  • Recent ocular trauma or intraocular surgery that is not resolved/stable or may affect visual outcomes
  • Any pupil abnormalities
  • 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
  • Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study
  • Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical study
  • Planned monovision correction
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566083


Locations
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United States, California
Empire Eye & Laser Center
Bakersfield, California, United States, 93309
Sponsors and Collaborators
Abbott Medical Optics

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Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT02566083     History of Changes
Other Study ID Numbers: TIOL-202-TPAS
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases