Trials / Completed
CompletedNCT03050697
Evaluation of the Safety and Performance of the HARMONI® Toric Lens
A Prospective, Multicenter Study to Evaluate the Safety and Performance of the Exchangeable ClarVista HARMONI Modular Toric Intraocular Lens System for the Treatment of Pre-Existing Corneal Astigmatism and Aphakia Following Cataract Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- ClarVista Medical · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to evaluate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic (HMTIOL) in subjects with pre-existing corneal astigmatism in need of cataract surgery.
Detailed description
Subjects with visually significant bilateral cataracts (cortical, nuclear, posterior subcapsular, or a combination) were implanted unilaterally (in one eye only) or bilaterally (in both eyes) with the HMTIOL. A total of 7 study visits were planned, including a preoperative visit, operative visits for each eye, and 4 follow-up visits at 1 day, 1 week, 1 month, and 3 months postoperative. The total duration of participation for each subject was up to 6 months, including the preoperative period (up to 3 months). 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 Toric Intraocular Lens | Two-component system consisting of a base and a separate toric optic |
| PROCEDURE | Cataract extraction with intraocular lens (IOL) implantation | Cataract removal via manual phacoemulsification, followed by HMTIOL implantation |
Timeline
- Start date
- 2016-09-28
- Primary completion
- 2017-06-07
- Completion
- 2017-07-28
- First posted
- 2017-02-13
- Last updated
- 2020-06-12
- Results posted
- 2020-06-11
Locations
1 site across 1 country: New Zealand
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03050697. Inclusion in this directory is not an endorsement.