Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population
NCT04755231 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 181
Last updated 2023-10-10
Summary
The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.
Conditions
- Aphakia
- Presbyopia
Interventions
- DEVICE
-
AcrySof IQ PanOptix Presbyopia Correcting IOL
UV and blue-light filtering foldable multifocal IOL with a +2.17 diopter (D) addition power of intermediate visual acuity and a +3.25 D addition power of near visual acuity. This device is approved in China.
- PROCEDURE
-
Cataract surgery
Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ PanOptix Presbyopia Correcting IOL
Sponsors & Collaborators
-
Alcon Research
lead INDUSTRY
Principal Investigators
-
Sr. Clinical Project Manager, Surgical · Alcon (China) Ophthalmic Product Co., Ltd.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-19
- Primary Completion
- 2022-08-31
- Completion
- 2023-03-15
- FDA Device
- Yes
Countries
- China
Study Locations
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