Trials / Completed
CompletedNCT06469541
Clinical Outcomes After Implantation of a Monofocal Hydrophobic IOL, Bi-Flex 877PAY With POB-MA Preloaded Injector
Clinical Outcomes After Implantation of a Monofocal Hydrophobic IOL, Bi-Flex 877PAY With POB-MA Preloaded Injector: Visual Outcomes, Refractive Stability, Safety Features, YAG Capsulotomy Rate. (Retrospective Review)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Medicontur Medical Engineering Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed 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
Conditions
Timeline
- Start date
- 2023-04-11
- Primary completion
- 2023-07-31
- Completion
- 2023-12-01
- First posted
- 2024-06-21
- Last updated
- 2024-06-21
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT06469541. Inclusion in this directory is not an endorsement.