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

This study is currently recruiting participants.
Verified April 2017 by Bausch & Lomb Incorporated
Sponsor:
ClinicalTrials.gov Identifier:
NCT01060787
First Posted: February 2, 2010
Last Update Posted: April 25, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  Purpose
Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants

Condition Intervention
Inflammation Uveitis Procedure: Fluocinolone Acetonide 0.59 mg Procedure: Fluocinolone Acetonide 2.1 mg

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

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


Estimated Enrollment: 100
Actual Study Start Date: February 4, 2016
Estimated Study Completion Date: May 5, 2018
Estimated Primary Completion Date: March 6, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

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.


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
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
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


Contacts
Contact: Anya Loncaric 510-782-2286 aloncaric@solta.com

Locations
United States, Massachusetts
Ophthalmic Partners of Boston Recruiting
Boston, Massachusetts, United States, 02114
Contact: Michael Raziman, MD         
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Johnson Varughese Valeant Pharmaceuticals/Bausch & Lomb
  More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01060787     History of Changes
Other Study ID Numbers: 440
First Submitted: January 29, 2010
First Posted: February 2, 2010
Last Update Posted: April 25, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Inflammation
Uveitis
Pathologic Processes
Uveal Diseases
Eye Diseases
Fluocinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs