Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to assess the rate of early intraocular pressure (IOP) increases following implantation of EVO/EVO+ Implantable Collamer Lens (ICL).
This study will be conducted at up to 10 sites in the US, by surgeons qualified by experience and training to implant the EVO/EVO+ lens.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVO ICL | Other | STAAR EVO implantable collamer lens (ICL) for the correction or reduction of myopia or myopia with astigmatism. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVO ICL | Device | The EVO ICL is 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 |
|---|---|---|
| Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg | The number of primary (first implanted) eyes that have elevated intraocular pressure measuring ≥ 30 mmHg as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea. | 1-6 hours postoperatively |
| Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG | The number of primary (first implanted) eyes that have elevated intraocular pressure measuring ≥ 40 mmHG as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea. | 1-6 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg | The number of fellow (second implanted) eyes that have elevated intraocular pressure measuring ≥ 30 mmHg as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea. | 1-6 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD | Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye. | 1-6 hours postoperatively |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joanne Egamino, PhD | Staar Surgical Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aloha Laser Vision, LLC | Honolulu | Hawaii | 96814 | United States | ||
| Durrie Vision |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
205 subjects were enrolled and treated at 8 clinical sites in the United States. The first enrolled subject underwent surgery in the primary eye on 05 Oct 2022 and the last eye was implanted on 21 Sep 2023.
| ID | Title | Description |
|---|---|---|
| FG000 | Primary Eyes | First implanted eyes of enrolled subjects. EVO/EVO+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 | Second implanted eyes of enrolled subjects. EVO/EVO+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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline data were collected on the whole participant level
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EVO ICL | Enrolled patients who underwent surgery with an ICL lens in at least one eye. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 30 mmHg | The number of primary (first implanted) eyes that have elevated intraocular pressure measuring ≥ 30 mmHg as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea. | Posted | Count of Units | Eyes | 1-6 hours postoperatively | Eyes | Eyes |
|
|
Collection of adverse events began at the time of informed consent and continued until study completion (approximately 2-3 weeks)
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Treated Eyes | EVO/EVO+ ICL: the investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior chamber of the human crystalline lens. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incorrect EVO ICL Implantation | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraocular Pressure Increased | Eye disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joanne Egamino | STAAR Surgical | 626-303-7902 | 2905 | jegamino@staar.com |
Not provided
| 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 | Apr 25, 2023 | Oct 15, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
All enrolled subjects will undergo phakic eye surgery to have the STAAR EVO Implantable Collamer Lens (ICL) implanted in one or both eligible eyes.
Not provided
Not provided
Not provided
Not provided
| Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG |
The number of fellow (second implanted) eyes that have elevated intraocular pressure measuring ≥ 40 mmHG as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea. |
| 1-6 hours postoperatively |
| Cumulative Rates in Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes | Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes. | 1-6 hours postoperatively |
| Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD | Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye. | Day 1 postoperatively |
| Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes | Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes. | Day 1 postoperatively |
| Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD | Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye. | Day 5-9 postoperatively |
| Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes | Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes. | Day 5-9 postoperatively |
| Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD | Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye. | Day 10-18 postoperatively |
| Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes | Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes | Day 10-18 postoperatively |
| Overland Park |
| Kansas |
| 66210 |
| United States |
| Kugler Vision, PC | Omaha | Nebraska | 68118 | United States |
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | 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 |
| The Eye Institute of Utah | Salt Lake City | Utah | 84107 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
| Eyes |
|
|
| Primary | Elevated Intraocular Pressure (IOP) in Primary Eyes ≥ 40 mmHG | The number of primary (first implanted) eyes that have elevated intraocular pressure measuring ≥ 40 mmHG as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea. | Posted | Count of Units | Eyes | 1-6 hours postoperatively | Eyes | Eyes |
|
|
|
| Secondary | Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 30 mmHg | The number of fellow (second implanted) eyes that have elevated intraocular pressure measuring ≥ 30 mmHg as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea. | Posted | Count of Units | Eyes | 1-6 hours postoperatively | Eyes | Eyes |
|
|
|
| Secondary | Elevated Intraocular Pressure (IOP) in Fellow Eyes ≥ 40 mmHG | The number of fellow (second implanted) eyes that have elevated intraocular pressure measuring ≥ 40 mmHG as assessed with applanation tonometry which is a noninvasive test that measures the pressure inside the eye by flattening a part of the cornea. | Posted | Count of Units | Eyes | 1-6 hours postoperatively | Eyes | Eyes |
|
|
|
| Other Pre-specified | Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD | Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye. | Posted | Count of Units | Eyes | 1-6 hours postoperatively | Eyes | Eyes |
|
|
|
| Other Pre-specified | Cumulative Rates in Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes | Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes. | Posted | Count of Units | Eyes | 1-6 hours postoperatively | Eyes | Eyes |
|
|
|
| Other Pre-specified | Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD | Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye. | Posted | Count of Units | Eyes | Day 1 postoperatively | Eyes | Eyes |
|
|
|
| Other Pre-specified | Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes | Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes. | Posted | Count of Units | Eyes | Day 1 postoperatively | Eyes | Eyes |
|
|
|
| Other Pre-specified | Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD | Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye. | Posted | Count of Units | Eyes | Day 5-9 postoperatively | Eyes | Eyes |
|
|
|
| Other Pre-specified | Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes | Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes. | Posted | Count of Units | Eyes | Day 5-9 postoperatively | Eyes | Eyes |
|
|
|
| Other Pre-specified | Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Retained OVD | Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to retained Ophthalmic Viscoelastic Device (OVD) a clear gel-like material used in eye surgery to maintain the volume and shape of the anterior chamber of the eye. | Posted | Count of Units | Eyes | Day 10-18 postoperatively | Eyes | Eyes |
|
|
|
| Other Pre-specified | Cumulative Rates of Increased Intraocular Pressure (IOP) in All Eyes Attributed to Other Causes | Rates of elevated intraocular pressure in all (primary + fellow) eyes attributed to other causes | Posted | Count of Units | Eyes | Day 10-18 postoperatively | Eyes | Eyes |
|
|
|
| 0 |
| 205 |
| 2 |
| 408 |
| 45 |
| 408 |
| Intraocular Lens Exchange | Eye disorders | Systematic Assessment |
|
| Intraocular Cilium | Eye disorders | Systematic Assessment |
|
| Surgery to Remove Intraocular Cilium | Eye disorders | Systematic Assessment |
|
All data generated from the study will be regarded as confidential, until appropriate analysis and review by the Sponsor or designee is completed. The results of the study may be published or presented by the Investigator(s) after review by, and in consultation and agreements 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 the Sponsor or designee for comment.