Cataract Clinical Trial
Official title:
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.
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