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Evaluation of Cataract Surgery Outcomes in Patients With Prior Laser Vision Correction Implanted With the CT LUCIA Lens
Sponsor: Carl Zeiss Meditec AG
Summary
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.
Official title: EPIC: Evaluation of the Postoperative Cataract Surgery Outcomes in Patients With Prior Corneal Laser Vision Correction Implanted With the CT LUCIA Intraocular Lens Protocol GPAS-SAS-023-4
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2025-07
Completion Date
2026-09
Last Updated
2025-07-24
Healthy Volunteers
No
Interventions
CT LUCIA 621P Intraocular Lens Implantation
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.
Locations (2)
Berkeley Eye Center
Sugar Land, Texas, United States
Piedmont Eye Center
Lynchburg, Virginia, United States