The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.
This study evaluated the safety and effectiveness of the Hoya Surgical Optics iSert Model 251 IOL following primary implantation for the visual correction of aphakia in adults in whom the cataractous lens has been removed by phacoemulsification. Results from this prospective, multicenter clinical trial will be used to support a PMA supplement for the iSert® 251 IOL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
aphakic intraocular lens
Schwartz Laser Eye Center
E. Shea Blvd, Suite C101, Arizona, United States
Katzen Eye Care and Laser Center
Boynton Beach, Florida, United States
Center for Excellence in Eye Care
Miami, Florida, United States
Eye Surgeons of Indiana
Indianapolis, Indiana, United States
Visual Acuity
BEST Spectacle-Correction (ETDRS) Distance Visual Acuity
Time frame: 4 to 6 months
Complications and Adverse Events
Number of Participants with Complications or Adverse Events
Time frame: 4 to 6 months
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Eye Health Vision Centers
North Dartmouth, Massachusetts, United States