Trials / Completed
CompletedNCT03681886
Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System (HMIOL)
Evaluation of Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- ClarVista Medical · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to evaluate visual and refractive outcomes with the use of the HARMONI™ Modular Intraocular Lens (HMIOL) System implantation, assembly, and optic exchange in subjects undergoing cataract surgery.
Detailed description
All subjects were implanted with the HARMONI™ Modular Intraocular Lens (HMIOL) System in the right eye, left eye, or both eyes based on the best interest of the subject and the clinical judgment the Investigator (Day 0, primary implantation) (Cohort 1). At Month 1 post primary implantation, subjects were given the option to undergo an optic exchange procedure. Subjects who underwent the optic exchange (Cohort 2) (Day 0, optic exchange) were followed for an additional month. Subjects who did not undergo an optic exchange were exited from the study, except at 1 site, which followed subjects up to Month 12. Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc. The study results were collected, analyzed, and provided by ClarVista Medical, Inc. to Alcon Research, LLC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Harmoni Modular Intraocular Lens | Two-component system consisting of a base and a separate optic that allows for an intraoperative exchange of the optic only without direct manipulation of the capsular bag. |
| PROCEDURE | Optic Exchange | Removal of one optic and replacement with another for the purpose of improving refractive outcomes |
Timeline
- Start date
- 2016-01-09
- Primary completion
- 2017-12-14
- Completion
- 2017-12-14
- First posted
- 2018-09-24
- Last updated
- 2021-01-05
- Results posted
- 2021-01-05
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03681886. Inclusion in this directory is not an endorsement.