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

June 20, 2019 updated by: Bausch & Lomb Incorporated

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Partners of Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects having the fluocinolone acetonide intravitreal implant (0.59 or 2.1 mg) in only one eye for at least one (1) year.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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:
  • Retisert
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:
  • Retisert

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Johnson Varughese, Valeant Pharmaceuticals/Bausch & Lomb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 4, 2016

Primary Completion (ACTUAL)

March 7, 2019

Study Completion (ACTUAL)

June 7, 2019

Study Registration Dates

First Submitted

January 29, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (ESTIMATE)

February 2, 2010

Study Record Updates

Last Update Posted (ACTUAL)

June 21, 2019

Last Update Submitted That Met QC Criteria

June 20, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 440

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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