Post-Approval Study of the Tecnis® Toric IOL



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:22 - Any
Updated:3/8/2019
Start Date:October 21, 2015
End Date:April 30, 2019

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Post-Approval Study of the Tecnis® Toric IOL, Models ZCT300 and ZCT400

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


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
We found this trial at
1
site
Bakersfield, California 93309
Principal Investigator: Daniel Chang, M.D
Phone: 661-432-7204
?
mi
from
Bakersfield, CA
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