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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Jul 31, 2025

Status verified

Jul 2025

Primary completion

Jul 31, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

30 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

Mean Prediction Error (PE) [ Time Frame: 3 months postoperatively ]

Central Contacts

• Henry Heering
  949-293-0520
  [email protected]

Locations (2)

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