NCT07084545

Evaluation of Cataract Surgery Outcomes in Patients With Prior Laser Vision Correction Implanted With the CT LUCIA Lens

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Carl Zeiss Meditec AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Visual Outcomes Following Cataract Surgery in Patients With Prior Myopic Corneal Laser Vision Correction

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2025-07-24
• Last updated: 2025-07-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study