We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01060787
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants

Condition or disease Intervention/treatment
Inflammation Uveitis Procedure: Fluocinolone Acetonide 0.59 mg Procedure: Fluocinolone Acetonide 2.1 mg

Detailed Description:
Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants on corneal endothelial cell density.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Bilateral Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant for at Least One Year
Actual Study Start Date : February 4, 2016
Actual Primary Completion Date : March 7, 2019
Actual Study Completion Date : June 7, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: Retisert


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Corneal Endothelial Cell Density [ Time Frame: 1 Visit ]
    Bilateral specular microscopy will be performed and endothelial cell density will be recorded.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060787


Locations
Layout table for location information
United States, Massachusetts
Ophthalmic Partners of Boston
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Layout table for investigator information
Study Director: Johnson Varughese Valeant Pharmaceuticals/Bausch & Lomb
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01060787    
Other Study ID Numbers: 440
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Uveitis
Inflammation
Pathologic Processes
Uveal Diseases
Eye Diseases
Fluocinolone Acetonide
 Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs