Myopia Clinical Trial
Official title:
A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens
Verified date | April 2024 |
Source | Staar Surgical Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Staar Surgical Company |
United States,
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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