Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant
An Observational Bilateral Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant for at Least One Year
1 other identifier
observational
98
1 country
1
Brief Summary
Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2010
CompletedFirst Posted
Study publicly available on registry
February 2, 2010
CompletedStudy Start
First participant enrolled
February 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2019
CompletedJune 21, 2019
June 1, 2019
3.1 years
January 29, 2010
June 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Corneal Endothelial Cell Density
Bilateral specular microscopy will be performed and endothelial cell density will be recorded.
1 Visit
Study Arms (2)
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.
Interventions
At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.
At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.
Eligibility Criteria
Subjects having the fluocinolone acetonide intravitreal implant (0.59 or 2.1 mg) in only one eye for at least one (1) year.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ophthalmic Partners of Boston
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson Varughese
Valeant Pharmaceuticals/Bausch & Lomb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2010
First Posted
February 2, 2010
Study Start
February 4, 2016
Primary Completion
March 7, 2019
Study Completion
June 7, 2019
Last Updated
June 21, 2019
Record last verified: 2019-06