Status:
COMPLETED
Study on Visual Performance of a Monofocal Intraocular Lens
Lead Sponsor:
Carl Zeiss Meditec AG
Conditions:
Cataract Senile
Eligibility:
All Genders
18+ years
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 18 2021
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04740788
Start Date
February 19 2021
End Date
May 18 2021
Last Update
August 17 2021
Active Locations (1)
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1
Borkenstein & Borkenstein
Graz, Austria, 8010