Status:
COMPLETED
AcrySof IQ Toric A-Code Post-Market Clinical Study
Lead Sponsor:
Alcon Research
Conditions:
Cataract
Astigmatism
Eligibility:
All Genders
20+ years
Phase:
NA
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 IO...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Eye conditions as specified in the protocol
- Uncontrolled glaucoma
- Pregnancy, current or planned
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
January 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2021
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT03350503
Start Date
January 30 2018
End Date
December 17 2021
Last Update
December 28 2022
Active Locations (4)
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1
Alcon Investigative Site
Hiroshima, Hiroshima, Japan, 733-0842
2
Alcon Investigative Site
Hakodate, Hokkaido, Japan, 040-0053
3
Alcon Investigative Site
Miyakonojō, Miyazaki, Japan, 885-0051
4
Alcon Investigative Site
Saga, Saga-ken, Japan, 840-0831