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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04283149
Other study ID # CP19-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 30, 2020
Est. completion date December 15, 2023

Study information

Verified date April 2024
Source Staar Surgical Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 327
Est. completion date December 15, 2023
Est. primary completion date April 5, 2021
Accepts healthy volunteers No
Gender All
Age group 21 Years to 45 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
EVO/EVO+ Visian ICL
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.

Locations

Country Name City State
United States Solomon Eye Physicians and Surgeons/Bowie Vision Institute Bowie Maryland
United States Cleveland Eye Clinic Brecksville Ohio
United States Key-Whitman Eye Center Dallas Texas
United States Hoopes Vision/Hoopes, Durrie, Rivera Research Draper Utah
United States Aloha Laser Vision, LLC Honolulu Hawaii
United States Price Vision Group, Indianapolis Indiana
United States Kremer Eye Center King Of Prussia Pennsylvania
United States Kugler Vision, PC Omaha Nebraska
United States Durrie Vision Overland Park Kansas
United States Barnett Dulaney Perkins Phoenix Arizona
United States Brinton Vision Saint Louis Missouri
United States The Eye Institute of Utah Salt Lake City Utah
United States Parkhurst NuVision San Antonio Texas
United States Vance Thompson Vision Sioux Falls South Dakota

Sponsors (1)

Lead Sponsor Collaborator
Staar Surgical Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 Months
Primary 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. 6 Months
Primary Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes. Number of eyes with ECD <1000 cells/mm² at month 6 in primary eyes. 6 months
Primary Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes. Number of eyes with ECD <1500 cells/mm² at month 6 in primary eyes. 6 months
Primary Number of Ocular Adverse Events (AEs) in Primary Eyes. 6 Months
Secondary 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. 6 Months
Secondary 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. 6 Months
Secondary 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. 6 months
Secondary 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. 6 months
Secondary Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes 6 Months
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