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
Not provided
Not provided
Not provided
Not provided
This is a prospective, Phase IV, post-approval observational study evaluating postoperative outcomes in patients with a history of myopic corneal laser vision correction (LVC) undergoing bilateral cataract surgery with implantation of the CT LUCIA 621P intraocular lens (IOL). Up to 30 subjects (60 eyes) will be enrolled across up to three U.S. investigational sites. The study will assess visual and refractive outcomes, including biometry, manifest refraction, and patient-reported visual function over a 3-month follow-up period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT LUCIA 621P IOL Implantation Group | Subjects with prior myopic corneal laser vision correction undergoing bilateral cataract surgery implanted with the CT LUCIA 621P intraocular lens. All subjects will be followed prospectively to assess postoperative visual and refractive outcomes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT LUCIA 621P Intraocular Lens Implantation | Device | The intervention consists of bilateral implantation of the CT LUCIA 621P intraocular lens (IOL) during routine cataract surgery in patients with a history of myopic corneal laser vision correction. The CT LUCIA 621P IOL is an approved, single-piece, hydrophobic acrylic lens designed to provide improved visual quality and refractive stability. Implantation is performed following each investigator's standard surgical procedures, including preoperative preparation, operative technique, and postoperative care. IOL power calculation uses the ZEISS Cataract Workflow platform with the VERACITY system and Barrett True-K with TK formula, incorporating the VERION Optical Coherence (VOC) technology. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Prediction Error (PE) | The average difference between postoperative manifest refraction spherical equivalent (MRSE) and predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula. | 3 months postoperatively |
| Median Prediction Error (PE) | The median difference between postoperative MRSE and predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula. | 3 months postoperatively |
| Absolute Prediction Error (PE) | The absolute value of the difference between postoperative MRSE and predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula. | 3 months postoperatively |
| Percentage of Eyes Within ±0.25 D of Predicted MRSE | The proportion of eyes achieving postoperative MRSE within ±0.25 D of the predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula. | 3 months postoperatively |
| Percentage of Eyes Within ±0.50 D of Predicted MRSE | The proportion of eyes achieving postoperative MRSE within ±0.50 D of the predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula. | 3 months postoperatively |
| Percentage of Eyes Within ±1.00 D of Predicted MRSE | The proportion of eyes achieving postoperative MRSE within ±1.00 D of the predicted MRSE based on IOLMaster 700 with Barrett True-K with TK formula. | 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Corrected Distance Visual Acuity (CDVA) | Monocular and binocular postoperative corrected distance visual acuity measured by standard methods. | 3 months postoperatively |
| Uncorrected Distance Visual Acuity (UDVA) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
This prospective Phase IV post-approval study will enroll up to 30 subjects (60 eyes) at up to three U.S. sites. Eligible adults undergoing bilateral cataract surgery with the CT LUCIA 621P IOL will be enrolled after providing informed consent. Subjects must meet all protocol-defined inclusion and exclusion criteria. Those with complete baseline and Month 3 postoperative biometry and manifest refraction data in both eyes will be considered evaluable. All implanted eyes will be included in safety and efficacy analyses.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henry Heering | Contact | 949-293-0520 | henry.heering@zeiss.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berkeley Eye Center | Recruiting | Sugar Land | Texas | 77478 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Monocular and binocular postoperative uncorrected distance visual acuity.
| 3 months postoperatively |
| Piedmont Eye Center | Recruiting | Lynchburg | Virginia | 24502 | United States |
|