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

Official title

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

Overview

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.

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 postoper

Primary outcome measures

• Mean Prediction Error (PE) [Time frame: 3 months postoperatively]
• Median Prediction Error (PE) [Time frame: 3 months postoperatively]
• Absolute Prediction Error (PE) [Time frame: 3 months postoperatively]
• Percentage of Eyes Within ±0.25 D of Predicted MRSE [Time frame: 3 months postoperatively]
• Percentage of Eyes Within ±0.50 D of Predicted MRSE [Time frame: 3 months postoperatively]
• Percentage of Eyes Within ±1.00 D of Predicted MRSE [Time frame: 3 months postoperatively]

Secondary outcome measures (2)

• Corrected Distance Visual Acuity (CDVA) [Time frame: 3 months postoperatively]
• Uncorrected Distance Visual Acuity (UDVA) [Time frame: 3 months postoperatively]

Eligibility criteria

Inclusion criteria

• Be at least 18 years of age or older.
• 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.
• 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.
• Clear intraocular media other than cataract (i.e., no hyphema, vitreous hemorrhage).
• No visual acuity limiting corneal or retinal pathologies.
• Able to and having provided written informed consent and a signed Health Insurance Portability and Accountability Act (HIPAA) form.
• Availability, willingness, ability, and sufficient cognitive awareness to comply with study examination procedures and the schedule for study visits and evaluations.

Exclusion criteria

• Implantation of an IOL other than the CT LUCIA 621P in one or both eyes.
• 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.
• Visual field loss which has an impact on visual acuity.
• Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that would confound visual acuity measurement.
• Subjects with surgical complications in whom a CT LUCIA 621P IOL cannot be implanted in either eye.
• 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.
• Subjects with planned ocular surgery during the study (except Nd:YAG capsulotomy is permitted).
• History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the opinion of the investigator, confound results.
• Current diagnosis of macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, or other chronic ocular conditions that would confound the study results.
• A current diagnosis of moderate or severe glaucoma.
• Patients with strabismus, forme fruste keratoconus, keratoconus or other corneal pathologies that would confound visual acuity measurement.
• Previous radial keratotomy (RK).
• Previous corneal keratoplasty (e.g., corneal transplant, Descemet's stripping automated endothelial keratoplasty (DSAEK), lamellar keratoplasty).
• Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy).
• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate under mesopic/scotopic conditions).
• Capsular or zonular abnormalities or other conditions that may affect the postoperative centration or tilt of the lens (e.g., pseudoexfoliation syndrome).
• Usage of contact lenses during study participation.
• Concurrent participation in another device investigation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 2 centers

• Berkeley Eye Center — Sugar Land
• Piedmont Eye Center — Lynchburg

Identifiers

NCT: NCT07084545 · GPAS-SAS-023-4

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗