Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant
Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Inflammation; Uveitis
Intervention: Fluocinolone Acetonide 0.59 mg (Procedure); Fluocinolone Acetonide 2.1 mg (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Bausch & Lomb Incorporated Official(s) and/or principal investigator(s): Johnson Varughese, Study Director, Affiliation: Valeant Pharmaceuticals/Bausch & Lomb
Overall contact: Anya Loncaric, Phone: 510-782-2286, Email: aloncaric@solta.com
Summary
Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants on corneal
endothelial cell density.
Clinical Details
Official title: An Observational Bilateral Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant for at Least One Year
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Corneal Endothelial Cell Density
Eligibility
Minimum age: 6 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Had the FA intravitreal implant (0. 59 or 2. 1 mg) in only one eye for at least one(1)
year
- Able and willing to follow instructions
- Able and willing to provide informed consent
Exclusion criteria:
- Is monocular
- Has current or relevant medical history that would interfere with their participation
in this study, based on the judgment of the Investigator
- Had bilateral FA intravitreal implants
- Has a history of any severe/serious ocular pathology or medical condition that could
result in the subject's inability to complete the study
Locations and Contacts
Anya Loncaric, Phone: 510-782-2286, Email: aloncaric@solta.com
Ophthalmic Partners of Boston, Boston, Massachusetts 02114, United States; Recruiting Michael Raziman, MD
Additional Information
Starting date: August 2006
Last updated: February 13, 2015
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