Post-Approval Study of the TECNIS® Toric Extended Cylinder Range Intraocular Lens (IOL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02649842|
Recruitment Status : Completed
First Posted : January 8, 2016
Results First Posted : December 27, 2019
Last Update Posted : January 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cataract Astigmatism||Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Post-Approval Study of the TECNIS® Toric IOL Extended Cylinder Range (ECR), Models ZCT450, ZCT525 and ZCT600|
|Actual Study Start Date :||March 21, 2016|
|Actual Primary Completion Date :||August 27, 2018|
|Actual Study Completion Date :||January 28, 2019|
Experimental: Extended Cylinder IOL
Approved toric intraocular lenses, Model ZCT450, ZCT525 or ZCT600
Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600
Approved toric intraocular lens
- Rate of Severe Visual Distortions [ Time Frame: 6 months ]Rate of severe visual distortions based on data from a self administered subject questionnaire
- Rate of IOL Repositioning Due to IOL Misalignment [ Time Frame: 6 months ]Rate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL
- Percent Change in Cylinder [ Time Frame: 6 months ]Percent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))*100
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649842
|Study Director:||Devi Priya Janakiraman, OD,FAAO||Abbott Medical Optics|