AcrySof IQ Toric A-Code Post-Market Clinical Study
- Conditions
- CataractAstigmatism
- Registration Number
- NCT03350503
- Lead Sponsor
- Alcon Research
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
- Diagnosis of cataracts with planned cataract removal by phacoemulsification
- Calculated lens power within the available range
- Able to sign informed consent and complete all study visits
- Other protocol-defined inclusion criteria may apply.
- Eye conditions as specified in the protocol
- Uncontrolled glaucoma
- Pregnancy, current or planned
- Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Percentage of Eyes With Absolute Value of Intraocular (IOL) Rotation (Visit 00 to Visit 4) Visit 00 (Day 0 operative), Visit 4 (Day 120-180 postoperative) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Alcon Investigative Site
🇯🇵Saga, Saga Prefecture, Japan
Alcon Investigative Site🇯🇵Saga, Saga Prefecture, Japan