Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant
Study Details
Study Description
Brief Summary
Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants on corneal endothelial cell density.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Fluocinolone Acetonide 0.59 mg Participants who have had the fluocinolone acetonide (FA) drug delivery system 0.59 mg surgically implanted in the ocular vitreous chamber of one (1) eye for at least one (1) year. |
Procedure: Fluocinolone Acetonide 0.59 mg
At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.
Other Names:
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Fluocinolone Acetonide 2.1 mg Participants who have had the fluocinolone acetonide (FA) drug delivery system 2.1 mg surgically implanted in the ocular vitreous chamber of one (1) eye for at least one (1) year. |
Procedure: Fluocinolone Acetonide 2.1 mg
At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Corneal Endothelial Cell Density [1 Visit]
Bilateral specular microscopy will be performed and endothelial cell density will be recorded.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Had the FA intravitreal implant (0.59 or 2.1 mg) in only one eye for at least one(1) year
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Able and willing to follow instructions
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Able and willing to provide informed consent
Exclusion criteria:
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Is monocular
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Has current or relevant medical history that would interfere with their participation in this study, based on the judgment of the Investigator
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Had bilateral FA intravitreal implants
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Has a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Ophthalmic Partners of Boston | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Johnson Varughese, Valeant Pharmaceuticals/Bausch & Lomb
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 440