Vitrectomy
Conditions
Keywords
Vitrectomy, Visualization
Brief summary
The purpose of this study is to evaluate the safety and efficacy of triamcinolone acetonide suspension when used for visualization of structures in the back of the eye during eye surgery.
Interventions
Approximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients planning to undergo pars plana vitrectomy with good vision in the non-surgery eye. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Patients under 18. * Patients with previous vitrectomy, elevated intraocular pressure (IOP) and/or history of ocular inflammatory disease. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Visualization Score at Post-Instillation from Pre-Instillation | Day 0 | A video image of the posterior segment structures of the eye was taken before instillation of the test product and after. An independent masked reader evaluated the images and graded the degree of visualization on a 5-point scale ranging from 1 to 4 and anchored at the ends by Not Visible (0) and Clearly Delineated (4). The mean difference was calculated, and a higher number indicated increased visibility. |
Outcome results
None listed