Status:
COMPLETED
Long Term Safety Protocol for the AcrySof CACHET Phakic Lens
Lead Sponsor:
Alcon Research
Conditions:
Myopia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Subjects previously enrolled in protocols C-02-23 (NCT00726024), C-02-40 (NCT00727805), C-03-21 (NCT00726297), and C-05-57 (NCT00727688) who received an L-series lens either in the first eye or second...
Eligibility Criteria
Inclusion
- 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
- None
Key Trial Info
Start Date :
November 21 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2018
Estimated Enrollment :
657 Patients enrolled
Trial Details
Trial ID
NCT01497067
Start Date
November 21 2011
End Date
June 15 2018
Last Update
July 2 2019
Active Locations (1)
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1
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134