A Clinical Investigation of the ClarVista HARMONI™ Modular Intraocular Lens Implant Following Cataract Surgery

A Prospective, Multi-Center, Feasibility Trial of the ClarVista HARMONI™ Modular Intraocular Lens System for the Treatment of Aphakia Following Cataract Surgery

The main objectives of this feasibility study were:

• To demonstrate the feasibility of HARMONI Modular Intraocular Lens (HMIOL) implantation and assembly in subjects undergoing cataract surgery (All HMIOL Cohort), and
• To demonstrate the feasibility of the HMIOL optic component exchange procedure (performed 3 months following primary cataract extraction) (Cohort 2).

Eligible subjects with bilateral cataracts underwent cataract extraction and IOL implantation using phacoemulsification. The study eye was implanted with the investigational device (All HMIOL Cohort). The fellow eye was treated with a commercially available intraocular lens (IOL) per standard of care procedure. At the scheduled Month 3 post-operative visit, subjects who did not opt to pursue an optic exchange procedure in the study eye were enrolled into subgroup Cohort 1 and followed for an additional 6 months. The total duration of participation for Cohort 1 was up to 15 months, which included a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. At the scheduled Month 3 post-operative visit, subjects who elected to pursue an optic exchange procedure in the study eye were enrolled into subgroup Cohort 2 and followed for an additional 12 months. The total duration of participation for Cohort 2 was up to 18 months, which included a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period.

Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc., to evaluate the safety and effectiveness of the HMIOL. The study results were collected, analyzed, and provided by ClarVista Medical, Inc. to Alcon Research, LLC.

Inclusion Criteria:

• Must be able to understand and provide informed consent
• Must be willing and able to return for scheduled treatment and follow-up examinations for up to 15 month study duration
• Planned bilateral removal of visually significant bilateral cataracts
• Best-corrected distance visual acuity (BCDVA) projected to be better than 20/32 after IOL implantation in both eyes
• Preoperative bilateral BCDVA of 20/40 or worse
• Both eyes must have corneal astigmatism ≤ 1.50 diopter (D)
• Women must be post-menopausal ≥1 year or surgically sterilized, or a pregnancy screen must be performed prior to the study and a reliable form of contraception, approved by the investigator, must be maintained during the study
• Dilated pupil size equal to or greater than 6 millimeters (mm) in primary study eye
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Participation in any other drug or device clinical trial within 30 days prior to enrolling in this study and/or during study participation
• History of any intraocular or corneal surgery in either eye (including refractive)
• History of any clinically significant retinal pathology or ocular diagnosis in either eye
• History of any ocular conditions which could affect the stability of the IOL
• Uncontrolled glaucoma in either eye
• Other protocol-specified exclusion criteria may apply.