Study on Visual Performance of a Monofocal Intraocular Lens

Carl Zeiss Meditec

Status: Completed

Conditions: Cataract Senile

Treatments: Device: Monofocal IOL

Study type: Observational

Funder types: Industry

Identifiers

NCT04740788

GPAS-SUR-020-02

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

44 participants in 1 patient group

Monofocal IOL

Description:

Patients already implanted with a monofocal IOL

Treatment:

Device: Monofocal IOL