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

NCT07084545 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-07-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Carl Zeiss Meditec AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-07-31
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07084545 on ClinicalTrials.gov