Trials / Completed
CompletedNCT03010254
A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL)
A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus (EDF) IOL
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 322 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to demonstrate the safety and performance of the ACRYSOF® IQ EDF IOL.
Detailed description
Both eyes will be implanted. The second eye implantation will occur a minimum of 7 calendar days and a maximum of 28 calendar days from the first eye implantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ACRYSOF® IQ Extended Depth of Focus IOL | Implantable IOL intending to extend the depth of focus and provide continuous functional vision from distance to near while maintaining distance vision and a visual disturbance profile comparable to a monofocal IOL; intended for long-term use over the lifetime of the pseudophakic subject |
| DEVICE | ACRYSOF® IQ Monofocal IOL | Monofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject |
| PROCEDURE | Cataract surgery | IOL bilateral implantation |
Timeline
- Start date
- 2017-03-21
- Primary completion
- 2018-08-17
- Completion
- 2018-10-31
- First posted
- 2017-01-05
- Last updated
- 2020-04-07
- Results posted
- 2020-04-07
Locations
21 sites across 4 countries: Australia, Canada, Spain, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03010254. Inclusion in this directory is not an endorsement.