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

Completed

• Conditions: Inflammation; Uveitis
• Interventions: Procedure: Fluocinolone Acetonide 0.59 mg; Procedure: Fluocinolone Acetonide 2.1 mg

• Registration Number: NCT01060787
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Study Timeline

• Study First Submitted: 2010-01-29
• Study First Submitted QC: 2010-02-01
• Study First Posted: 2010-02-02
• Study Start: 2016-02-04
• Primary Completion: 2019-03-07
• Status Verified: 2019-06
• Study Completion: 2019-06-07
• Last Update Submitted: 2019-06-20
• Last Update Posted: 2019-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fluocinolone Acetonide 0.59 mg	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	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.

Primary Outcome Measures

Name	Time	Method
Corneal Endothelial Cell Density	1 Visit	Bilateral specular microscopy will be performed and endothelial cell density will be recorded.

Trial Locations

Locations (1)

Ophthalmic Partners of Boston; 🇺🇸 Boston, Massachusetts, United States