Cataract Clinical Trial
Official title:
Post-Approval Study of the TECNIS® Toric IOL Extended Cylinder Range (ECR), Models ZCT450, ZCT525 and ZCT600
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.
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.
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