Vitreous Inflammation Clinical Trial
Official title:
Vitreous Nonsteroidal Antiinflammatory Drus Concentrations And Prostaglandin E2 Levels in Vitrectomy Patients Treated With Indomethacin 0.5%, Bromfenac 0.09%, and Nepafenac 0.1%
The purpose of this study is to assess vitreous concentrations of nonsteroidal
antiinflammatory drugs (NSAIDs) and prostaglandin E2 in patients treated with NSAIDs before
vitrectomy.
A total of 0.5 to 1 mL undiluted vitreous was removed from the midvitreous cavity at the
beginning of the surgery before infusion with balanced salt solution. Samples were
immediately frozen and stored at -40°C until analysis. Samples were evaluated in a masked
fashion. Vitreous concentrations of the study drugs were quantified using a reverse-phase
liquid chromatography mass spectroscopy system. The minimum quantification limit for
ketorolac, bromfenac, nepafenac, and amfenac was 0.8 ng/mL. Prostaglandin E2 concentrations
were determined using a commercially available competitive enzyme immunoassay kit (R & D
Systems, Minneapolis, MN).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02675543 -
Vitreous Inflammation in Standard and Heavy Silicone Oil
|
N/A |