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| Name | Class |
|---|---|
| Sengi Clinical | UNKNOWN |
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This prospective study evaluates the visual and refractive outcomes of the TECNIS Odyssey intraocular lens (IOL) implanted in patients with a history of myopic LASIK. Given the unique optical challenges of post-LASIK eyes, including altered corneal curvature and higher-order aberrations, the study aims to assess the IOL's performance in terms of distance, intermediate, and near vision, and patient satisfaction. Its design features may offer favorable outcomes in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Odyssey IOL | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Odyssey intraocular lens | Device | The Odyssey intraocular lens is intended to be implanted at the time of cataract surgery to replace the natural lens. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binocular defocus curve | The defocus curve assesses a patient's visual performance at various distances by introducing different levels of lens defocus (measured in diopters) and recording the corresponding visual acuity. It provides a comprehensive evaluation of the range of clear vision (distance, intermediate, and near) offered by an intraocular lens. | 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Percentage of patients who reported being completely, mostly, moderately, a little or not at all satisfied with overall vision | 3 months postoperatively |
| Spectacle independence at near. |
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Inclusion Criteria:
Subjects MUST fulfill the following conditions to qualify for enrollment into the trial
Exclusion Criteria:
Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.
The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates the patient is unsuitable for the trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helga P Sandoval | Contact | 8438813937 | hps@cepmd.com |
| Name | Affiliation | Role |
|---|---|---|
| Joaquin K De Rojas, MD | Center For Sight | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center For Sight | Recruiting | Venice | Florida | 34285 | United States |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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Percentage of patients who reported wearing glasses none of the time or a little of the time for near activities (16 inches/40 cm).
| 3 months postoperatively |