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

Bausch + Lomb

Status: Completed

Conditions: Inflammation; Uveitis

Treatments: Procedure: Fluocinolone Acetonide 2.1 mg; Procedure: Fluocinolone Acetonide 0.59 mg

Study type: Observational

Funder types: Industry

Identifiers

NCT01060787

440

Details and patient eligibility

About

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

Full description

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

Enrollment: 98 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

98 participants in 2 patient groups

Fluocinolone Acetonide 0.59 mg

Description:

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.

Treatment:

Procedure: Fluocinolone Acetonide 0.59 mg

Fluocinolone Acetonide 2.1 mg

Description:

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.

Treatment:

Procedure: Fluocinolone Acetonide 2.1 mg