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| Name | Class |
|---|---|
| Science in Vision | OTHER |
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The purpose of this study is to evaluate the lens vault after implantation of an implantable collamer lens (ICL). The ICL is designed to be implanted in front of the eye, without removing the natural lens. Because of this, it is also known as a phakic IOL. The ICL has already been approved by the U.S. Food and Drug Administration (FDA) to treat mid to high degrees of refractive errors such nearsightedness (also called myopia) with or without astigmatism. Once the artificial lens is implanted, a space between the ICL and the crystalline lens is created, which is called vault.
The ICL will be implanted in both eyes of study subjects. Diagnostic instrumentation will be used to measure the vault between the ICL and the crystalline lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICL | Other | ICL implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable Collamer Lens | Device | The EVO ICL lens is intended to be placed entirely within the posterior chamber directly behind the iris and in front of the anterior capsule of the human crystalline lens. When correctly positioned, the EVO ICL lens functions as a refractive element to optically reduce moderate to high myopia with or without astigmatism. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference Between Predicted and Actual Central Vault at 1-month After ICL Implantation | Difference between the predicted vault at the preoperative visit and the actual vault measured at the 1-month visit | 1-month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerry Solomon, MD | Carolina Eyecare Physicians | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helga Sandoval | Mt. Pleasant | South Carolina | 29464 | United States |
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Enrollment was expected to be 33 per the protocol, but enrollment proved difficult. 21 subjects were screened, with one screen failure. Twenty subjects started and completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | ICL Implantation Group | ICL implantation Implantable Collamer Lens: The EVO ICL lens is intended to be placed entirely within the posterior chamber directly behind the iris and in front of the anterior capsule of the human crystalline lens. When correctly positioned, the EVO ICL lens functions as a refractive element to optically reduce moderate to high myopia with or without astigmatism. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ICL Implantation Group | ICL implantation Implantable Collamer Lens: The EVO ICL lens is intended to be placed entirely within the posterior chamber directly behind the iris and in front of the anterior capsule of the human crystalline lens. When correctly positioned, the EVO ICL lens functions as a refractive element to optically reduce moderate to high myopia with or without astigmatism. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Difference Between Predicted and Actual Central Vault at 1-month After ICL Implantation | Difference between the predicted vault at the preoperative visit and the actual vault measured at the 1-month visit | Patients with ICL placed horizontally were included in the analysis. | Posted | Mean | Standard Deviation | Milimeters | 1-month | eyes | eyes |
|
1 month
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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 | ICL Implantation Group | ICL implantation Implantable Collamer Lens: The EVO ICL lens is intended to be placed entirely within the posterior chamber directly behind the iris and in front of the anterior capsule of the human crystalline lens. When correctly positioned, the EVO ICL lens functions as a refractive element to optically reduce moderate to high myopia with or without astigmatism. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Carolina Eyecare Physicians, LLC | 8438813937 | hsandoval@cepmd.com |
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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 | Dec 19, 2023 | Jan 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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All subjects were implanted with the EVO ICL
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| eyes |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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