This objective of this study is to evaluate the safety, and to collect supportive data on effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in study participants who have a diagnosis of myopia or myopia with astigmatism. Primary study analysis will be evaluated when 300 primary eyes complete 6 months of follow-up. Final study analysis will be assessed when all treated eyes complete 36 months of follow-up.
This study will be conducted at up to 20 clinical sites in the United States by surgeons qualified by training and experience to implant STAAR ICLs.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
327
The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Barnett Dulaney Perkins
Phoenix, Arizona, United States
Aloha Laser Vision, LLC
Honolulu, Hawaii, United States
Price Vision Group,
Indianapolis, Indiana, United States
Number of Primary Eyes Requiring Peripheral Iridotomy (PI)
Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary eyes.
Time frame: 6 Months
Endothelial Cell Density (ECD) Change in Primary Eyes.
Endothelial Cell Density (ECD) was determined by analysis of images captured by a specular microscopy device. These images were analyzed by a reading center to determine ECD values before surgery and 6 months after surgery to calculate the mean change (% decrease) of ECD from baseline at month 6 in primary eyes. Negative outcome values represent a reduction in Endothelial Cell Density.
Time frame: 6 Months
Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.
Number of eyes with ECD \<1000 cells/mm² at month 6 in primary eyes.
Time frame: 6 months
Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.
Number of eyes with ECD \<1500 cells/mm² at month 6 in primary eyes.
Time frame: 6 months
Number of Ocular Adverse Events (AEs) in Primary Eyes.
Time frame: 6 Months
Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI)
Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary and fellow eyes.
Time frame: 6 Months
Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes.
Endothelial Cell Density (ECD) was determined by analysis of images captured by a specular microscopy device. These images were analyzed by a reading center to determine ECD values before surgery and 6 months after surgery to calculate the mean change (% decrease) of ECD from baseline at month 6 in primary eyes and fellow eyes. Negative outcome values represent a reduction in Endothelial Cell Density.
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Durrie Vision
Overland Park, Kansas, United States
Solomon Eye Physicians and Surgeons/Bowie Vision Institute
Bowie, Maryland, United States
Brinton Vision
St Louis, Missouri, United States
Kugler Vision, PC
Omaha, Nebraska, United States
Cleveland Eye Clinic
Brecksville, Ohio, United States
Kremer Eye Center
King of Prussia, Pennsylvania, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
...and 4 more locations
Time frame: 6 Months
Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes.
Number of eyes with ECD \<1000 cell/mm² at month 6 in primary and fellow eyes.
Time frame: 6 months
Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes.
Number of eyes with ECD \<1500 cell/mm² at month 6 in primary and fellow eyes.
Time frame: 6 months
Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes
Time frame: 6 Months