Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant

Overview

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

Full Title of Study: “An Observational Bilateral Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant for at Least One Year”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 7, 2019

Detailed Description

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

Interventions

  • Procedure: Fluocinolone Acetonide 0.59 mg
    • At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.
  • Procedure: Fluocinolone Acetonide 2.1 mg
    • At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Corneal Endothelial Cell Density
    • Time Frame: 1 Visit
    • Bilateral specular microscopy will be performed and endothelial cell density will be recorded.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bausch & Lomb Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Johnson Varughese, Study Director, Valeant Pharmaceuticals/Bausch & Lomb

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