Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants
Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants on corneal endothelial cell density.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluocinolone Acetonide 0.59 mg | Procedure | At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Endothelial Cell Density | Bilateral specular microscopy will be performed and endothelial cell density will be recorded. | 1 Visit |
Not provided
Not provided
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Subjects having the fluocinolone acetonide intravitreal implant (0.59 or 2.1 mg) in only one eye for at least one (1) year.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johnson Varughese | Valeant Pharmaceuticals/Bausch & Lomb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Partners of Boston | Boston | Massachusetts | 02114 | United States |
Not provided
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005446 | Fluocinolone Acetonide |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Fluocinolone Acetonide 2.1 mg | Procedure | At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density. |
|
|
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |