Visual Performance of Patients Implanted With a Multifocal IOL (VISUAL)

Carl Zeiss Meditec

Status

Active, not recruiting

Conditions

Cataract

Refractive Lens Exchange

Treatments

Device: AT ELANA

Study type

Interventional

Funder types

Industry

Identifiers

NCT06111222

GPAS-SUR-021-01

Details and patient eligibility

About

The goal of this clinical trial is to learn about the visual performance of a new multifocal intra-ocular lens in patients presenting for cataract or refractive lens exchange surgery. The main question it aims to answer is: What is the visual performance and patient satisfaction twelve months post-operatively? Participants will receive bilateral implantation of the investigational device, undergo post-operative assessments, and provide feedback on their overall visual satisfaction.

Enrollment

87 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 18 years or older;
Patients scheduled for bilateral AT ELANA 841P phacoemulsification cataract extraction or Femtosecond-Laser-Assisted-Cataract-Surgery (cataract grades of 1, 2, 3 on the LOCSIII scale) and IOL implantation (Cataract or PRELEX) with a maximum of 28 days between both implantations; Calculated IOL power within the limited IOL Diopter range of +15.0D to +27.0D
No visual acuity limiting pathologies other than cataract;
Corneal Astigmatism of <1.0 D;
Availability, willingness, and sufficient cognitive awareness to comply with examination procedures;
Written informed consent for participation in the study and data protection.

Exclusion criteria

Corneal Astigmatism of ≥1.0 D;
Difficulty for cooperation (distance from their home, general health conditions);
History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the surgeon's opinion, confound results (e.g., corneal pathology, OHT, glaucoma suspect, glaucoma, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc.);
Visual field loss which has an impact on visual acuity;
Use of systemic or ocular medication that might affect vision;
Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus;
Pupil abnormalities (non-reactive, tonic pupils, abnormal myosis or mydriasis, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions);
Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g., pseudoexfoliation syndrome);
Cataract grades of 4, 5 or 6 on the LOCSIII scale ;
Surgeries with incision size of ≥2.75mm ;
Immediate Sequential Bilateral Cataract Surgery ;
Concurrent participation in another device investigation;
Usage of contact lenses during participation.