The purpose of this study is to clinically confirm the rotational stability of a modified AcrySof IQ toric intraocular lens (IOL) in a Japanese population.
Patients will be examined pre-operatively to up to 3 years post-operatively. One eligible eye will be selected as a target eye for efficacy analysis. If both eyes are eligible, the eye in which the IOL is implanted first will be selected as the target eye.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient
Removal of cataractous lens and implantation of IOL
Alcon Investigative Site
Hiroshima, Hiroshima, Japan
Alcon Investigative Site
Hakodate, Hokkaido, Japan
Alcon Investigative Site
Miyakonojō, Miyazaki, Japan
Alcon Investigative Site
Saga, Saga-ken, Japan
Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4)
IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. No confirmatory hypothesis testing was conducted.
Time frame: Visit 00 (Day 0 operative), Visit 4 (Day 120-180 postoperative)
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