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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Eyes | Experimental | First implanted eyes of enrolled participants |
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| Fellow Eyes | Experimental | Second implanted eyes of enrolled participants |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVO/EVO+ Visian ICL | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Number of Ocular Adverse Events (AEs) in Primary Eyes. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Egamino, PhD | VP, Global Clinical Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnett Dulaney Perkins | Phoenix | Arizona | 85106 | United States | ||
| Aloha Laser Vision, LLC |
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327 subjects were enrolled and treated at 14 clinical sites in the US. The first enrolled subject underwent surgery in the primary eye in January 2020 and the last eye was implanted in December 2020.
| ID | Title | Description |
|---|---|---|
| FG000 | Primary Eyes | First implanted eyes of enrolled participants 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. |
| FG001 | Fellow Eyes |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2020 |
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All enrolled eyes will undergo phakic eye surgery to have one of the available implantable collamer lenses EVO or EVO+ (spherical or toric) ICL implanted in their primary eye. Fellow eye surgery will occur between 7 and 14 days after primary eye surgery.
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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 |
| 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 |
| 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 |
| Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes | 6 Months |
| Honolulu |
| Hawaii |
| 96814 |
| United States |
| Price Vision Group, | Indianapolis | Indiana | 46260 | United States |
| Durrie Vision | Overland Park | Kansas | 66210 | United States |
| Solomon Eye Physicians and Surgeons/Bowie Vision Institute | Bowie | Maryland | 20716 | United States |
| Brinton Vision | St Louis | Missouri | 63141 | United States |
| Kugler Vision, PC | Omaha | Nebraska | 68118 | United States |
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |
| Kremer Eye Center | King of Prussia | Pennsylvania | 19406 | United States |
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | United States |
| Key-Whitman Eye Center | Dallas | Texas | 75243 | United States |
| Parkhurst NuVision | San Antonio | Texas | 78229 | United States |
| Hoopes Vision/Hoopes, Durrie, Rivera Research | Draper | Utah | 84020 | United States |
| The Eye Institute of Utah | Salt Lake City | Utah | 84107 | United States |
Second implanted eyes of enrolled participants 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. |
| Postoperative Month 6 |
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| COMPLETED |
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| NOT COMPLETED |
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Enrolled patients who underwent surgery with an investigational lens in at least one eye.
| ID | Title | Description |
|---|---|---|
| BG000 | EVO ICL | Enrolled patients who underwent surgery with an investigational lens in at least one eye |
| Units | Counts |
|---|---|
| Participants |
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| Eyes |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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| Preoperative Manifest Refraction Spherical Equivalent | Mean preoperative Manifest Refraction Spherical Equivalent. | 327 participants were enrolled with analysis presented for primary eye (n=327) and fellow eye (n=302) | Mean | Standard Deviation | Diopters | Eyes |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | eyes | 6 Months | Eyes | Eyes |
|
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| 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. | Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit. | Posted | Mean | 95% Confidence Interval | percentage change | 6 Months | Eyes | Eyes |
|
| ||||||||||||||||||||||||||
| 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. | Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit. | Posted | Number | 95% Confidence Interval | eyes | 6 months | Eyes | Eyes |
|
| ||||||||||||||||||||||||||
| 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. | Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit. | Posted | Number | 95% Confidence Interval | eyes | 6 months | Eyes | Eyes |
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| Primary | Number of Ocular Adverse Events (AEs) in Primary Eyes. | Posted | Number | events | 6 Months | Eyes | Eyes |
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| 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. | Posted | Number | eyes | 6 Months | Eyes | Eyes |
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| 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. | Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit. | Posted | Mean | 95% Confidence Interval | percentage change | 6 Months | Eyes | Eyes |
|
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| 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. | Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit. | Posted | Number | 95% Confidence Interval | Eyes | 6 months | Eyes | Eyes |
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| 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. | Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit. | Posted | Number | 95% Confidence Interval | eyes | 6 months | Eyes | Eyes |
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| Secondary | Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes | Posted | Number | events | 6 Months | Eyes | Eyes |
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6 months.
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. The study protocol required that all secondary surgical interventions (SSIs) performed to treat an ocular SAE also be reported as SAEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primary Eyes | 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. | 0 | 327 | 10 | 327 | 82 | 327 |
| EG001 | Fellow Eyes | 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. | 0 | 302 | 6 | 302 | 65 | 302 |
| EG002 | Non-Ocular Serious Adverse Events | Participants who experienced a non-ocular Serious Adverse Event. | 0 | 327 | 2 | 327 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glare/Halo | Eye disorders | Systematic Assessment |
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| Narrow anterior chamber angle | Eye disorders | Systematic Assessment |
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| Retinal detachment | Eye disorders | Systematic Assessment |
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| Retinal tear | Eye disorders | Systematic Assessment |
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| Intraocular lens exchange | Eye disorders | Systematic Assessment |
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| Intraocular lens removal | Eye disorders | Systematic Assessment |
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| Intraocular lens repositioning | Eye disorders | Systematic Assessment |
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| Retinal Surgery | Eye disorders | Systematic Assessment |
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| Amnesia | Nervous system disorders | Systematic Assessment |
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| Cerebral Infarction | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraocular pressure increased | Eye disorders | Systematic Assessment |
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| Anterior chamber cell/flare | Eye disorders | Systematic Assessment |
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All data generated from the study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee are completed. The results of the study may be published or presented by the Investigator(s) after review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed. Prior to publication or presentation, a copy of the final text should be forwarded to Sponsor or designee for comment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joanne Egamino | STAAR Surgical | 626-303-7902 | 2905 | jegamino@staar.com |
| Apr 8, 2022 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Title | Measurements |
|---|---|
| Female |
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| Male |
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| Title | Measurements |
|---|---|
| Hispanic or Latino |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
| American Indian or Alaska Native |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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