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The aim of this study is to investigate the 3-month visual performance of the CT LUCIA 621P IOL, a hydrophobic aspheric monofocal IOL with a non-constant aspheric optic profile in adult patients 50 years of age or older who are undergoing cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral implantation of investigational device | Experimental | Monofocal IOL |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT LUCIA 621P | Device | The device under investigation, CT LUCIA 621P IOL (Carl Zeiss Meditec, Jena, Germany) is a posterior chamber intraocular lens which is indicated for aphakia after surgical extraction of the cataractous natural lens. It is a monofocal aspheric IOL made of hydrophobic material and coated with heparin. The modified C-loop haptic is step-vaulted. |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular best corrected distance visual acuity (CDVA) | The primary efficacy endpoint is the proportion of patients with monocular CDVA of 20/40 or better at three months | Three (3) Months |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Corrected Distance Visual Acuity | Three (3) Months | |
| Monocular Uncorrected Distance Visual Acuity | Three (3) Months | |
| Monocular Distance Corrected Intermediate Visual Acuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grant Sharpe | Contact | +447918937014 | grant.sharpe@zeiss.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Price Vision Group | Not yet recruiting | Indianapolis | Indiana | 46260 | United States |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Three (3) Months |
| Monocular Uncorrected Intermediate Visual Acuity | Three (3) Months |
| Manifest Refraction Spherical Equivalent | Three (3) Months |
| Refractive Predictability | Manifest refraction will be evaluated at 1 and 3 months to determine refractive predictability. The predicted refraction is the goal or target refraction from the IOLMaster IOL calculation and the observed refraction is the 3 Month postoperative Manifest Refraction Spherical Equivalent measurement. | Three (3) Months |
| Refractive Stability | Manifest refraction will be obtained at 1 and 3 months to evaluate whether refractive stability is achieved by 3 months. Refractive stability will be evaluated at the 1 to 3 months interval as a parameter of interest to determine the proportion of eyes that achieve stability of manifest refraction. | Three (3) Months |
| Contrast Sensitivity - mesopic and photopic with and without glare | Three (3) Months |
| Huffman & Huffman PSC | Recruiting | Lexington | Kentucky | 40509 | United States |
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| The Pennsylvania State University and Penn State Health | Not yet recruiting | Hershey | Pennsylvania | 17033 | United States |
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| Asociación Para Evitar La Ceguera en México, I.A.P. | Not yet recruiting | Mexico City | Alcaldia Coyoacan | C.P. 04030 | Mexico |
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