Evaluation of Cataract Surgery Outcomes in Patients With Prior Laser Vision Correction Implanted With the CT LUCIA Lens
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCarl Zeiss Meditec AG
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CT LUCIA 621P Intraocular Lens Implantation
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov