Evaluation of a Monofocal Intraocular Lens (PRECISE)

Carl Zeiss Meditec

Status and phase

Enrolling

Phase 4

Conditions

Cataract

Treatments

Device: CT LUCIA 621P

Study type

Interventional

Funder types

Industry

Identifiers

NCT06428955

GPAS-SAS-023-01

Details and patient eligibility

About

The aim of this study is to investigate the 3-month visual performance of the CT LUCIA 621P IOL, a hydrophobic aspheric monofocal IOL with a non-constant aspheric optic profile in adult patients 50 years of age or older who are undergoing cataract surgery.

Enrollment

44 estimated patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Be at least 50 years of age or older, male or female, of any race or ethnicity.
Presenting for uncomplicated bilateral cataract surgery for age-related cataract.
Planned bilateral cataract extraction with posterior chamber IOL implantation, via phacoemulsification with or without femtosecond laser assisted cataract surgery (FLACS).
Bilateral implantation of a CT LUCIA 621P IOL with a dioptric power between +10.00 D and +30.00 D and a target postoperative refraction of emmetropia (0.00 ±0.50 D).
Clear intraocular media other than cataract (i.e. no hyphema, vitreous hemorrhage)
No visual acuity limiting pathologies other than cataract. Best corrected postoperative visual acuity potential of 20/25 or better in both eyes as estimated by potential acuity meter or surgeon estimation.
Provide written informed consent and a signed HIPPA form.
Availability, willingness, ability, and sufficient cognitive awareness to comply with study examination procedures and the schedule for study visits and evaluations.

Exclusion criteria

Corneal Astigmatism of >1.0 D.
Planned monocular cataract extraction.
Visual field loss which has an impact on visual acuity.
Subjects with intraoperative surgical complications in whom a CT LUCIA 621P IOL cannot be implanted.
History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the surgeon's opinion, confound results (e.g., corneal pathology, keratoconus, strabismus, uncontrolled glaucoma)
History of Glaucoma, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc.
Previous intraocular or corneal surgery, including all forms of refractive surgery that might confound the outcome of the investigation or increase the risk to the subject
Previous anterior or posterior chamber surgery other than peripheral retinal barrier laser, SLT/ALT (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 increase the risk of zonular rupture during cataract extraction procedure and/or may affect the postoperative centration or tilt of the lens
Use of a systemic or ocular medication that might affect vision and confound the outcome or increase the risk to the subject in the opinion of the investigator such as tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome)
Cycloplegic pupil diameter <6.0 mm or the presence of ocular implants that limit pupil diameter (malyugin rings; iris prosthesis).
Usage of contact lenses during study participation
Pregnant, lactating during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes
Presence or history or any other condition or finding that, in the investigator's opinion, makes the subject unsuitable as a candidate for study participation, may increase the operative risk or may confound the outcome of the study.