Multicentric Retrospective/Prospective Study on Visual Performance of a Monofocal Intraocular Lens (IOL)

Carl Zeiss Meditec AG1 site in 1 country44 target enrollmentFebruary 19, 2021

ConditionsCataract Senile

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataract Senile
Sponsor: Carl Zeiss Meditec AG
Enrollment: 44
Locations: 1
Primary Endpoint: Best corrected distance visual acuity (CDVA)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Retrospective/Prospective Study on Visual Performance of a Monofocal Intraocular Lens (IOL). The objective is to compare best corrected distance visual acuity (CDVA) between 1-3-month and 12- month follow-up.

Registry

clinicaltrials.gov

Start Date

February 19, 2021

End Date

May 18, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Carl Zeiss Meditec AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 years or older;
•Patients with monolateral or bilateral (only one eye will be the study eye) monofocal IOL implantation after uncomplicated surgery in the period between May 2019 and November 2019, if the follow-up visit can be performed 10-18 months after surgery;
•No visual acuity limiting pathologies;
•Availability of 1-3-month postoperative data
•Availability, willingness and sufficient cognitive awareness to comply with examination procedures in case of a prospective 12-month visit;
•Written informed consent for participation in the study and data protection.

Exclusion Criteria

•Difficulty for cooperation (distance from their home, general health conditions)
•Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that would confound visual acuity measurements;
•Subjects with surgical complications or secondary interventions (except for Nd:YAG capsulotomy) related to the cataract surgery of the monofocal IOL eye(s) or any other interventions in the post-operative eye including but not limited to glaucoma surgery, retinal surgery;
•Visual field loss which has impact on visual acuity;
•Use of systemic or ocular medication that might affect vision;
•Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus;
•Capsular or zonular abnormalities that have affected postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome);
•Concurrent participation in another device investigation.