A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Staar Surgical Company
- Enrollment
- 327
- Locations
- 14
- Primary Endpoint
- Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Moderate to high myopia or myopic astigmatism correctable with available EVO/EVO+ ICL powers.
- •Stable refractive history within 0.50 D each cylinder and spherical equivalent (SE) for 1 year prior to implantation.
- •Able and willing to return for scheduled follow-up examinations after surgery.
- •Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)-approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
- •Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- •Insulin-dependent diabetes or diabetic retinopathy.
- •History of previous ocular surgery.
- •Cataract of any grade.
- •Monocular.
- •Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study.
- •Other protocol-specified exclusion criteria may apply.
Arms & Interventions
Primary Eyes
First implanted eyes of enrolled participants
Intervention: EVO/EVO+ Visian ICL (Device)
Fellow Eyes
Second implanted eyes of enrolled participants
Intervention: EVO/EVO+ Visian ICL (Device)
Outcomes
Primary Outcomes
Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes.
Time Frame: 6 months
Number of eyes with ECD \<1000 cells/mm² at month 6 in primary eyes.
Endothelial Cell Density (ECD) Change in Primary Eyes.
Time Frame: 6 Months
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.
Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes.
Time Frame: 6 months
Number of eyes with ECD \<1500 cells/mm² at month 6 in primary eyes.
Number of Ocular Adverse Events (AEs) in Primary Eyes.
Time Frame: 6 Months
Number of Primary Eyes Requiring Peripheral Iridotomy (PI)
Time Frame: 6 Months
Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary eyes.
Secondary Outcomes
- Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes.(6 months)
- Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes.(6 months)
- Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI)(6 Months)
- Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes(6 Months)
- Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes.(6 Months)