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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Visual Outcomes Following Cataract Surgery in Patients With Prior Myopic Corneal Laser Vision Correction
• Intervention / Treatment: Device: CT LUCIA 621P Intraocular Lens Implantation

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Henry Heering; Phone Number: 949-293-0520; Email: henry.heering@zeiss.com

Study Locations

• United States
  • Texas
    • Sugar Land, Texas, United States, 77478
      • Recruiting
      • Berkeley Eye Center
      • Principal Investigator: Morgan Micheletti, MD
      • Contact: Tetiana Huff; Phone Number: 2262 281-944-2251; Email: tetiana.huff@berkeleyeye.com
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Recruiting
      • Piedmont Eye Center
      • Principal Investigator: James Paauw, MD
      • Contact: Mishael Benjamin; Phone Number: 434-528-2020; Email: MBenjamin@piedmonteye.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Be at least 18 years of age or older.
2. Previous cornea LVC surgery performed at least 1 year before the implantation of the CT LUCIA 621P IOL, such as Laser-Assisted Intrastromal Keratomileusis (LASIK), Laser-Assisted Subepithelial Keratectomy (LASEK), Photorefractive Keratectomy (PRK) or Small Incision Lenticule Extraction (SMILE) for mild to moderate myopia, with or without astigmatism (up to, but not including, -6.0 D sphere in any meridian for myopic ablations.
3. Presenting for planned bilateral cataract extraction with in-the-bag posterior chamber IOL implantation, via phacoemulsification with or without femtosecond laser assisted cataract surgery (FLACS). Astigmatism management techniques, such as Astigmatic Keratotomy (AK), may be utilized during cataract surgery to target a predicted postoperative cylinder less than 0.75 D.
4. Clear intraocular media other than cataract (i.e., no hyphema, vitreous hemorrhage).
5. No visual acuity limiting corneal or retinal pathologies.
6. Able to and having provided written informed consent and a signed Health Insurance Portability and Accountability Act (HIPAA) form.
7. Availability, willingness, ability, and sufficient cognitive awareness to comply with study examination procedures and the schedule for study visits and evaluations.

Exclusion Criteria:

1. Implantation of an IOL other than the CT LUCIA 621P in one or both eyes.
2. Eyes with preoperative anterior corneal astigmatism of ΔTK ≥1.00 D as measured by the IOLMaster 700 or with greater than 0.75 D predicted post-operative astigmatism at the spectacle plane.
3. Visual field loss which has an impact on visual acuity.
4. Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that would confound visual acuity measurement.
5. Subjects with surgical complications in whom a CT LUCIA 621P IOL cannot be implanted in either eye.
6. Eyes with irregular corneal astigmatism, epithelial basement membrane dystrophy, chronic dry eye requiring continual treatment, underwent more than one LVC procedure in one or both eyes, or complications from the previous LVC which required additional surgical intervention.
7. Subjects with planned ocular surgery during the study (except Nd:YAG capsulotomy is permitted).
8. History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the opinion of the investigator, confound results.
9. Current diagnosis of macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, or other chronic ocular conditions that would confound the study results.
10. A current diagnosis of moderate or severe glaucoma.
11. Patients with strabismus, forme fruste keratoconus, keratoconus or other corneal pathologies that would confound visual acuity measurement.
12. Previous radial keratotomy (RK).
13. Previous corneal keratoplasty (e.g., corneal transplant, Descemet's stripping automated endothelial keratoplasty (DSAEK), lamellar keratoplasty).
14. Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy).
15. Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate under mesopic/scotopic conditions).
16. Capsular or zonular abnormalities or other conditions that may affect the postoperative centration or tilt of the lens (e.g., pseudoexfoliation syndrome).
17. Usage of contact lenses during study participation.
18. Concurrent participation in another device investigation.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	Monocular and binocular postoperative uncorrected distance visual acuity.	3 months postoperatively

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: July 15, 2025
• First Submitted That Met QC Criteria: July 22, 2025
• First Posted (Actual): July 24, 2025

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: GPAS-SAS-023-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No