N/A N=657 Other

Long Term Safety Protocol for the AcrySof CACHET Phakic Lens

Myopia

Bottom Line

View on ClinicalTrials.gov: NCT01497067 ↗

Enrolled (actual)

657

Serious AEs

16.9%

Results posted

Jun 2019

Primary outcome: Primary: Central Endothelial Cell Density (All Eyes) — 2654.0; 2639.0; 2633.0; 2551.0 cells/mm^2

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ACRYSOF CACHET Phakic Lens (L-series) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Jun 2018

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	—

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.

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

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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.