Post-Approval Study of the TECNIS® Toric Extended Cylinder Range Intraocular Lens (IOL)
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 22 - Any |
Updated: | 3/8/2019 |
Start Date: | March 21, 2016 |
End Date: | January 28, 2019 |
Post-Approval Study of the TECNIS® Toric IOL Extended Cylinder Range (ECR), Models ZCT450, ZCT525 and ZCT600
Post-Approval study to evaluate the rates of severe visual distortions for patients requiring
correction of approximately 3.00 D to 4.75 D of corneal astigmatism.
correction of approximately 3.00 D to 4.75 D of corneal astigmatism.
Inclusion Criteria:
- Minimum 22 years of age
- Bilateral cataracts
- Preoperative keratometric cylinder of at least 2.00 D in both eyes with at least one
eye having approximately 3.00 D to 4.75 D of corneal astigmatism.
- 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 or 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
- 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 or is lactating
We found this trial at
20
sites
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