Cataract surgery outcomes after prior myopic laser vision correction with the CT LUCIA 621P 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

The CT LUCIA 621P lens will be tried in people who had prior myopic laser vision correction to see if cataract surgery restores their vision and refraction.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Carl Zeiss Meditec AG (Industry-sponsored)
• Locations: 2 sites (Sugar Land, Texas and 1 other locations)
• Trial ID: NCT07084545 on ClinicalTrials.gov

What this trial studies

This is a prospective, phase IV post-approval observational study enrolling up to 30 subjects (60 eyes) across up to three U.S. investigational sites who undergo bilateral cataract extraction with implantation of the CT LUCIA 621P intraocular lens. Eligible participants have a history of myopic corneal laser vision correction performed at least one year prior and will receive standard phacoemulsification with or without femtosecond laser assistance. Outcomes include visual acuity, refractive results, biometry, manifest refraction, and patient-reported visual function collected over a 3-month follow-up. The study is non-randomized and focuses on real-world postoperative performance in this specific post-LVC population.

Who should consider this trial

Good fit: Adults aged 18 or older who had prior myopic corneal LVC at least one year earlier and are planning bilateral cataract extraction with in-the-bag posterior chamber IOL implantation are ideal candidates.

Not a fit: Patients with hyperopic ablations, significant corneal scarring or irregularity, active ocular disease, or major posterior segment pathology are unlikely to benefit from the findings of this lens-focused observational evaluation.

Why it matters

Potential benefit: If successful, the results could help eye doctors choose the CT LUCIA 621P and optimize IOL power selection for patients with prior myopic LVC, improving postoperative vision and reducing dependence on corrective lenses.

How similar studies have performed: Previous studies of IOL implantation after myopic LVC have generally shown acceptable visual outcomes but variable refractive predictability, and data specifically on the CT LUCIA 621P in this population remain limited.

Eligibility criteria

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.

Where this trial is running

Sugar Land, Texas and 1 other locations

• Berkeley Eye Center — Sugar Land, Texas, United States (Recruiting)
• Piedmont Eye Center — Lynchburg, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Henry Heering

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