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Summary
The objective of the study is to assess the long-term safety and effectiveness of the CorVision® microlens implanted in presbyopic patients for the management of management of presbyopia and near vision impairment. Approximately 100 patients in the Czech Republic will participate in this study. The study was reviewed and approved by an independent research ethics committee and also by the State Institute for Drug Control (SÚKL). The study will consist of a single visit during which standard, non-invasive, and painless examinations will be performed. This visit will correspond to the 4-year follow-up visit of the original clinical trial.
Official title: Four Years Extended Follow-Up on CorVision® Bioengineered Corneal Microlens: Safety and Efficacy
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
95
Start Date
2025-06-27
Completion Date
2025-11-25
Last Updated
2026-06-03
Healthy Volunteers
No
Conditions
Locations (1)
Gemini Eye Clinic
Zlín, Czechia