Study on Visual Performance of a Monofocal Intraocular Lens
NCT ID: NCT04740788
Last Updated: 2021-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
44 participants
OBSERVATIONAL
2021-02-19
2021-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Monofocal IOL
Patients already implanted with a monofocal IOL
Monofocal IOL
Patients are already implanted with a monofocal lens
Interventions
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Monofocal IOL
Patients are already implanted with a monofocal lens
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Carl Zeiss Meditec AG
INDUSTRY
Responsible Party
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Locations
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Borkenstein & Borkenstein
Graz, , Austria
Countries
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Other Identifiers
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GPAS-SUR-020-02
Identifier Type: -
Identifier Source: org_study_id
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