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 |
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
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
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