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Clinical Trials/NCT01060787
NCT01060787
Completed
N/A

An Observational Bilateral Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant for at Least One Year

Bausch & Lomb Incorporated1 site in 1 country98 target enrollmentFebruary 4, 2016
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ConditionsInflammationUveitis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Inflammation
Sponsor
Bausch & Lomb Incorporated
Enrollment
98
Locations
1
Primary Endpoint
Corneal Endothelial Cell Density
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants

Detailed Description

Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants on corneal endothelial cell density.

Registry
clinicaltrials.gov
Start Date
February 4, 2016
End Date
June 7, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Corneal Endothelial Cell Density

Time Frame: 1 Visit

Bilateral specular microscopy will be performed and endothelial cell density will be recorded.

Study Sites (1)

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