Trials / Completed
CompletedNCT04755231
Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population
Post-Market Clinical Study of the AcrySof® IQ PanOptix® Presbyopia Correcting Intraocular Lens in a Chinese Population
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 181 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.
Detailed description
In this clinical study, subjects will be implanted with the PanOptix IOL in both eyes. The second eye surgery will occur 7-28 days after the first eye. A total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. The total expected duration of the subject's participation will be about 14 months. This study will be conducted in China.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-04-19
- Primary completion
- 2022-08-31
- Completion
- 2023-03-15
- First posted
- 2021-02-16
- Last updated
- 2023-10-10
- Results posted
- 2023-10-10
Locations
9 sites across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04755231. Inclusion in this directory is not an endorsement.