Study on Visual Performance of a Monofocal Intraocular Lens

NCT04740788 | Completed

• 1 other identifier: GPAS-SUR-020-02
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Senile

Outcome Measures

Primary Outcomes (1)

• Best corrected distance visual acuity (CDVA)

  Comparison between 1-3-month and 12- month follow-up results.

  12 months

Study Arms (1)

Monofocal IOL

Patients already implanted with a monofocal IOL

Device: Monofocal IOL

Interventions

Monofocal IOL DEVICE

Patients are already implanted with a monofocal lens

Monofocal IOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cataract patients already implanted with a monofocal IOL

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead

Study Sites (1)

Borkenstein & Borkenstein

Graz, 8010, Austria

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: February 19, 2021
• Primary Completion: May 18, 2021
• Study Completion: May 18, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

AU (1)