Trials / Completed
CompletedNCT04126187
AcrySof® Bilateral PanOptix(R) Spectacle Freedom and Patient Satisfaction Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (actual)
- Sponsor
- Gainesville Eye Associates · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- —
Summary
The objective of this study is to assess the spectacle independence of patients receiving the AcrySof® Panoptix® Intraocular lens (IOL) after uneventful cataract surgery.
Detailed description
This study is a single-arm unmasked clinical evaluation study of spectacle independence after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a spectacle independence questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Panoptix | Panoptix trifocal intraocular lens (IOL) |
Timeline
- Start date
- 2020-05-14
- Primary completion
- 2021-03-30
- Completion
- 2021-03-30
- First posted
- 2019-10-15
- Last updated
- 2023-09-21
- Results posted
- 2021-08-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04126187. Inclusion in this directory is not an endorsement.