Study on Visual Performance of a Monofocal Intraocular Lens

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract Senile
• Intervention / Treatment: Device: Monofocal IOL

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8010
    • Borkenstein & Borkenstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cataract patients already implanted with a monofocal IOL

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Monofocal IOL; Patients already implanted with a monofocal IOL	Device: Monofocal IOL; Patients are already implanted with a monofocal lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected distance visual acuity (CDVA)	Comparison between 1-3-month and 12- month follow-up results.	12 months

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2021
• Primary Completion (Actual): May 18, 2021
• Study Completion (Actual): May 18, 2021

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: GPAS-SUR-020-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No