Trials / Completed
CompletedNCT03170154
Clinical Investigation of the Clareon® Intraocular Lens (IOL)
Clinical Investigation of the Clareon® IOL
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 376 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to compare visual acuity and adverse event outcomes from the Clareon intraocular lens (IOL) to historical safety and performance endpoint (SPE) rates.
Detailed description
Upon meeting eligibility criteria, subjects were implanted unilaterally (in one eye) with a Clareon IOL. Subjects attended 7 study visits over a period of approximately 13 months, including 1 preoperative screening visit (Visit 0), 1 operative visit (Visit 00), and 5 postoperative visits (Visits 1-5). Visit day calculations for Visits 1-5 were based off of the day of surgery (Visit 00). Primary endpoint data was collected at the final visit (Month 12). Some sites/subjects participated in a Rotational Stability sub-study. For the non-study eye, the investigator followed standard of care regarding the follow-up, surgery, and intraocular lens choice (as applicable). The non-study eye (fellow eye) was not implanted with the Clareon IOL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Clareon aspheric hydrophobic acrylic monofocal IOL | Ultraviolet-absorbing and blue light-filtering IOL composed of high refractive-index foldable and flexible acrylic material. IOLs are implantable medical devices intended for long term use over the lifetime of the cataract subject. |
Timeline
- Start date
- 2017-07-25
- Primary completion
- 2019-02-15
- Completion
- 2019-02-15
- First posted
- 2017-05-30
- Last updated
- 2020-08-03
- Results posted
- 2020-03-09
Locations
16 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03170154. Inclusion in this directory is not an endorsement.