Myopia, Myopic Astigmatism
Conditions
Keywords
Nearsightedness, Phakic intraocular lens (IOL), ICL, Toric ICL, EVO, EVO+, Visian
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.
Interventions
DEVICEEVO/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.
Sponsors
Staar Surgical Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Primary Eyes Requiring Peripheral Iridotomy (PI) | 6 Months | Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary eyes. |
| Endothelial Cell Density (ECD) Change in Primary Eyes. | 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) <1000 Cells/mm² in Primary Eyes. | 6 months | Number of eyes with ECD \<1000 cells/mm² at month 6 in primary eyes. |
| Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes. | 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. | 6 Months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI) | 6 Months | Incidence of PI required to treat elevated intraocular pressure (IOP) caused by mechanical pupillary block in primary and fellow eyes. |
| Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes. | 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 and fellow eyes. Negative outcome values represent a reduction in Endothelial Cell Density. |
| Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes. | 6 months | Number of eyes with ECD \<1000 cell/mm² at month 6 in primary and fellow eyes. |
| Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes. | 6 months | Number of eyes with ECD \<1500 cell/mm² at month 6 in primary and fellow eyes. |
| Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes | 6 Months | — |
Countries
United States
Contacts
STUDY_DIRECTORJoanne Egamino, PhD
VP, Global Clinical Affairs
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| EVO ICL Enrolled patients who underwent surgery with an investigational lens in at least one eye | 327 |
| EVO ICL Enrolled patients who underwent surgery with an investigational lens in at least one eye | 629 |
| Total | 956 |
Baseline characteristics
| Characteristic | EVO ICL |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 327 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 293 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Preoperative Manifest Refraction Spherical Equivalent Fellow Eyes | -7.61 Diopters STANDARD_DEVIATION 2.72 |
| Preoperative Manifest Refraction Spherical Equivalent Primary Eyes | -7.63 Diopters STANDARD_DEVIATION 2.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 38 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 274 Participants |
| Region of Enrollment United States | 327 participants |
| Sex: Female, Male Female | 213 Participants |
| Sex: Female, Male Male | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 327 | 0 / 302 | 0 / 327 |
| other Total, other adverse events | 82 / 327 | 65 / 302 | 0 / 0 |
| serious Total, serious adverse events | 10 / 327 | 6 / 302 | 2 / 327 |
Outcome results
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.
Time frame: 6 months
Population: Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Eyes | Endothelial Cell Density (ECD) <1000 Cells/mm² in Primary Eyes. | 0 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.
Time frame: 6 months
Population: Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Eyes | Endothelial Cell Density (ECD) <1500 Cells/mm² in Primary Eyes. | 0 eyes |
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.
Time frame: 6 Months
Population: Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Primary Eyes | Endothelial Cell Density (ECD) Change in Primary Eyes. | -2.4 percentage change |
Primary
Number of Ocular Adverse Events (AEs) in Primary Eyes.
Time frame: 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Eyes | Number of Ocular Adverse Events (AEs) in Primary Eyes. | 108 events |
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.
Time frame: 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Eyes | Number of Primary Eyes Requiring Peripheral Iridotomy (PI) | 0 eyes |
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.
Time frame: 6 months
Population: Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Eyes | Endothelial Cell Density (ECD) <1000 Cell/mm² in Primary and Fellow Eyes. | 0 Eyes |
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.
Time frame: 6 months
Population: Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Eyes | Endothelial Cell Density (ECD) <1500 Cell/mm² in Primary and Fellow Eyes. | 0 eyes |
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.
Time frame: 6 Months
Population: Analysis is based on examination data available at both the pre-operative visit and at the 6-month visit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Primary Eyes | Endothelial Cell Density (ECD) Change in Primary and Fellow Eyes. | -2.26 percentage change |
Secondary
Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes
Time frame: 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Eyes | Number of Ocular Adverse Events (AEs) in Primary and Fellow Eyes | 203 events |
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.
Time frame: 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Eyes | Number of Primary and Fellow Eyes Requiring Peripheral Iridotomy (PI) | 0 eyes |