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Clinical Trial Summary

The purpose of our investigation is to retrospectively assess visual outcomes, refractive stability, safety features of the lens and the incidence of developing PCO (posterior capsular opacification) in a 12-month period following mono- or bilateral implantation of the hydrophobic acrylic monofocal IOL, Bi-Flex 877PAY (Medicontur).


Clinical Trial Description

The purpose of our investigation is to retrospectively assess visual outcomes, refractive stability, safety features of the lens and the incidence of developing PCO (posterior capsular opacification) in a 12-month period following mono- or bilateral implantation of the hydrophobic acrylic monofocal IOL, Bi-Flex 877PAY (Medicontur). - Primary objective: o To evaluate the monocular Uncorrected Distance Visual Acuity (UCDVA) 1 year after IOL implantation - Secondary objectives: - To evaluate the spherical equivalent refraction one month postoperatively. - To evaluate level of astigmatism one month postoperatively. - To evaluate the Uncorrected Distance Visual Acuity (UDVA) monocular at 1 day, 1 month and 6 months after IOL implantation - To evaluate the Best Corrected Distance Visual Acuity (CDVA) monocular at 1 month, 6 months and 1 year after IOL implantation - To evaluate safety features of the lens - To evaluate PCO development, Nd:YAG capsulotomy rate ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06469541
Study type Observational
Source Medicontur Medical Engineering Ltd
Contact
Status Completed
Phase
Start date April 11, 2023
Completion date December 1, 2023

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