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

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.

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.

Key Inclusion Criteria:

• Planned removal of visually significant bilateral cataract by manual phacoemulsification cataract extraction
• Pre-existing corneal astigmatism in at least 1 eye of 0.75 to 2.50 diopter (D)
• Target dioptric lens power within the range of 16 - 26 D
• Willing to discontinue contact lens wear for the duration of the study
• BCVA projected to be ≤0.2 logarithm minimum angle of resolution (LogMAR)
• Stable cornea
• Dilated pupil size at least 7.0 millimeters (mm)
• Able to understand and provide informed consent.

Key Exclusion Criteria:

• History of any intraocular or corneal surgery in study eye (including refractive)
• Pregnant or lactating
• History of any clinically significant retinal pathology or ocular diagnosis in study eye that could alter or limit final postoperative visual prognosis
• History of ocular conditions which could affect the stability of the IOL in study eye
• Any anterior segment pathology likely to increase the risk of complications from phacoemulsification cataract extraction in study eye
• Any visually significant intraocular media opacity other than cataract in study eye
• Uncontrolled glaucoma in study eye
• Uncontrolled systemic disease
• Severe dry eye that would impair the ability to obtain reliable study measurements
• Systemic medication that may confound the outcome or increase the intraoperative and postoperative risk to the subject.