This record was last updated November 16, 2018 (before its estimated December 2023 completion). Its status may not reflect the trial's current state.
Summary
The objective of the PAS-01 study is to assess the safety of the intraocular as measured by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best corrected distance visual acuity \>2 lines from pre-surgery baseline level).
The study will test the null hypothesis that the percentage of patients who experience persistent vision-impairing corneal edema is \>17% against the alternative that the percentage is \<17%. The null hypothesis will be rejected if the upper bound of the two-sided 95% confidence integral for the observed percentage is \<17%.
Protocol Amendment History
6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2012-12-20; most recent amendment 2018-11-15.