Post-Approval Study of the TECNIS® Toric Extended Cylinder Range Intraocular Lens (IOL)

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, multicenter, bilateral, non-randomized, open-label, clinical study conducted at up to 20 sites in the USA. Subjects were to be bilaterally implanted with one eye having an extended cylinder (high cylinder) toric IOL (model ZCT450, ZCT525 or ZCT600) and the fellow eye having a high cylinder toric IOL (model ZCT450, ZCT525 or ZCT600) or a lower cylinder toric IOL (ZCT300 or ZCT400). This study evaluates the outcomes for subjects implanted with at least one higher cylinder toric IOL.

Detailed Description
-----------------
The purpose of this study is to evaluate the performance of the higher cylinder (ZCT450,ZCT525 and ZCT600) toric IOLs. Some subjects had the higher cylinder toric IOLs in both eyes with other subjects having a higher cylinder toric IOL in one eye and the lower cylinder toric IOL in the other eye. Per the statistical plan, data for the ZCT450/525/600 toric IOLs were to be pooled together and reported as one group. The primary endpoint is the rate of severe visual distortions reported by subject at 6 months via questionnaire. The analysis population for this endpoint will be bilaterally implanted subjects with a high cylinder IOL (ZCT450/525/600) in the primary eye and a high cylinder IOL (ZCT450/525/600) or a low cylinder IOL (ZCT300/400) in the fellow eye. There were no formal secondary endpoints. Data from a few other endpoints (rate of IOL repositioning due to IOL misalignment and percent change in cylinder) have been reported. For these endpoints the analysis population contains all subjects implanted with a ZCT450/525/600 in at least one eye. Adverse events were reported by subject for all subjects with a high cylinder IOL (ZCT450/525/600) in at least one eye.

Official Title
-----------------
Post-Approval Study of the TECNIS® Toric IOL Extended Cylinder Range (ECR), Models ZCT450, ZCT525 and ZCT600

Conditions
-----------------
Cataract, Astigmatism

Intervention / Treatment
-----------------
* Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended Cylinder IOL<br>Approved toric intraocular lenses, Model ZCT450, ZCT525 or ZCT600 | Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600<br>* Approved toric intraocular lens<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Severe Visual Distortions | Rate of severe visual distortions based on data from a self administered subject questionnaire | 6 months |