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.
Study Type
OBSERVATIONAL
Enrollment
95
Gemini Eye Clinic
Zlín, Czechia
Uncorrected Near Visual Acuity of 0.3 logMAR or better
More than 65% of the eyes should have an Uncorrected Near Visual Acuity (UNVA) of 0.3 logMAR or better at 4 years postoperatively.
Time frame: At least 4 years after the implantation
Implant removal
The incidence of implant rejection leading to implant removal should occur in no more than 3% of implanted eyes.
Time frame: At least 4 years after the implantation
Clinically significant corneal haze occurrence
Clinically significant corneal haze is defined as any new stromal clouding in or near the laser-created pocket that leads to a reduction in central corneal clarity/transparency, is visible upon slit-lamp examination, and is graded as ≥ 2 on a standardized corneal haze grading scale.
Time frame: At least 4 years after the implantation
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