18 and older, any sex, with Myopia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Central Endothelial Cell Density (All Eyes)Primary· Year 4 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57)
A microscope was used to photograph corneal endothelial cells (cells on the back of the cornea). Three images at the center of the cornea were obtained and sent to a central reading center for analysis. All recorded data from images were used in the analysis. A higher value for density represents a healthier cornea.
Year 4
Group
Value
95% CI
CACHET
2654.0
± 354.6
Year 5
Group
Value
95% CI
CACHET
2639.0
± 324.2
Year 5.5
Group
Value
95% CI
CACHET
2633.0
± 357.6
Year 6
Group
Value
95% CI
CACHET
2551.0
± 362.3
Year 6.5
Group
Value
95% CI
CACHET
2524.7
± 360.6
Year 7
Group
Value
95% CI
CACHET
2504.9
± 365.8
Year 7.5
Group
Value
95% CI
CACHET
2497.1
± 364.7
Year 8
Group
Value
95% CI
CACHET
2465.0
± 384.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this long term safety study is to estimate the annualized endothelial cell loss (ECL) rate (for up to 10 years following date of implantation) of subjects previously implanted with the ACRYSOF CACHET Phakic Intraocular Lens (L-series) from precursor clinical studies C-02-23, C-02-40, C-03-21 and C-05-57.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alcon Research
Last refreshed: 2 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01497067.