Long Term Safety Protocol for the AcrySof CACHET Phakic Lens
Long Term Safety Follow-up for Subjects Previously Implanted With the ACRYSOF® CACHET® Phakic Lens in Clinical Studies C-02-23, C-02-40, C-03-21 and C-05-57
1 other identifier
interventional
657
1 country
1
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 ACRYSOF CACHET Phakic Intraocular Lens (L-series) from precursor clinical studies C-02-23, C-02-40, C-03-21 and C-05-57.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 21, 2011
CompletedFirst Submitted
Initial submission to the registry
December 20, 2011
CompletedFirst Posted
Study publicly available on registry
December 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2018
CompletedResults Posted
Study results publicly available
June 26, 2019
CompletedJuly 2, 2019
June 1, 2019
6.6 years
December 20, 2011
June 3, 2019
June 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Central Endothelial Cell Density (All Eyes)
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 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57)
Study Arms (1)
CACHET
EXPERIMENTALACRYSOF CACHET Phakic Lens (L-series) previously implanted
Interventions
Intraocular lens for the treatment of moderate to high myopia
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Clinical Trial Lead, Surgical
- Organization
- Alcon Research
Study Officials
- STUDY DIRECTOR
Sr. Project Lead, Surgical
Alcon Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2011
First Posted
December 22, 2011
Study Start
November 21, 2011
Primary Completion
June 15, 2018
Study Completion
June 15, 2018
Last Updated
July 2, 2019
Results First Posted
June 26, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share