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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01060787
Enrollment
98
Registered
2010-02-02
Start date
2016-02-04
Completion date
2019-06-07
Last updated
2019-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Uveitis

Brief summary

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

Detailed description

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

Interventions

PROCEDUREFluocinolone Acetonide 0.59 mg

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

PROCEDUREFluocinolone Acetonide 2.1 mg

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

Sponsors

Bausch & Lomb Incorporated
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Corneal Endothelial Cell Density1 VisitBilateral specular microscopy will be performed and endothelial cell density will be recorded.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026