Multicentric Prospective Study on the Visual Performance of Patients Implanted With a Multifocal Intraocular Lens

Carl Zeiss Meditec AG3 sites in 2 countries87 target enrollmentOctober 31, 2023

ConditionsCataract Refractive Lens Exchange

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataract
Sponsor: Carl Zeiss Meditec AG
Enrollment: 87
Locations: 3
Primary Endpoint: Mean monocular best-corrected distance visual acuity (CDVA)
Status: Active, not recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 31, 2023

End Date

October 1, 2025

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Carl Zeiss Meditec AG

Responsible Party

Sponsor

Eligibility Criteria

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 ;