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Completed

NCT Number: NCT01060787

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

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

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Key information

Conditions

Inflammation Eye Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Uveal Diseases Uveitis

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ophthalmic Partners of Boston

Boston, Massachusetts, 02114, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluocinolone Acetonide 0.59 mg

Procedure

At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.

Other names: Retisert

Fluocinolone Acetonide 2.1 mg

Procedure

At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.

Other names: Retisert

Primary outcomes

  1. Corneal Endothelial Cell Density

    Time frame: 1 Visit

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

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 2, 2010
Registry last updated
Jun 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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