N/A
Completed N=657
Long Term Safety Protocol for the AcrySof CACHET Phakic Lens
Source: ClinicalTrials.gov NCT01497067 ↗Enrolled (actual)
657
Serious AEs
16.9%
Results posted
Jun 2019
Primary outcomePrimary: Central Endothelial Cell Density (All Eyes) — 2654.0; 2639.0; 2633.0; 2551.0 cells/mm^2
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Central Endothelial Cell Density (All Eyes) |
2654.0; 2639.0; 2633.0; 2551.0; 2524.7; 2504.9 | — |
Eligibility Criteria
Inclusion Criteria
- Previously implanted with an ACRYSOF CACHET Phakic Lens (L-Series) from clinical studies C-02-23, C-02-40, C-03-21 and C-05-57 and eligible for continued follow-up (i.e., exited from the previous study).
- Able to understand and sign a statement of informed consent.
- Willing and able to complete the yearly postoperative study visits.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01497067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.