NSAIDs and PGE2 Levels in Vitrectomy Patients

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Università degli Studi di Brescia
• Treatments: Anti-Inflammatory Agents; Bromfenac; Dinoprostone; Indomethacin; Ketorolac; Ketorolac Tromethamine; Nepafenac; Ophthalmic Solutions; Tetrahydrozoline

Criteria

Inclusion Criteria:

• patients with pucker scheduled for vitrectomy

Exclusion Criteria:

• diabetes

• active inflammation