Trials / Completed
CompletedNCT03479944
Clinical Evaluation of FLACS With Combination of LenSx® and Centurion®
Clinical Evaluation of FLACS (Femtosecond Laser Assisted Cataract Surgery) With Combination of LenSx® and Centurion®
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate cumulative dissipated energy (CDE), endothelial cell loss, and average torsional amplitude with combination of LenSx® and Centurion® compared to conventional cataract surgery.
Detailed description
Subjects will attend 7 scheduled visits: 1 pre-operative, 1 operative, and 5 post-operative.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | FLACS | Femtosecond laser assisted cataract surgery consisting of LenSx® and Centurion® combination |
| PROCEDURE | Manual conventional surgery | Removal of cataractous lens by phacoemulsification |
| DEVICE | CENTURION® Vision System | Phacoemulsification aspiration platform for use during cataract surgery |
| DEVICE | LenSx® | Femtosecond laser system used for continuous curvilinear capsulorhexis (CCC) and lens fragmentation during cataract surgery |
Timeline
- Start date
- 2018-08-22
- Primary completion
- 2018-11-19
- Completion
- 2019-05-17
- First posted
- 2018-03-27
- Last updated
- 2019-12-16
- Results posted
- 2019-12-16
Locations
1 site across 1 country: Japan
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03479944. Inclusion in this directory is not an endorsement.