Vitreous Inflammation
Conditions
Keywords
nonsteroidal antiinflammatory drugs, prostaglandin E2, vitrectomy
Brief 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).
Interventions
DRUGKetorolac 0.5% eyedrops
DRUGIndomethacin 0.5% eyedrops
DRUGBromfenac 0.09% eyedrops
Sponsors
Università degli Studi di Brescia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with pucker scheduled for vitrectomy
Exclusion criteria
* diabetes * active inflammation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prostaglandin E2 levels in the vitreous (pg/mL) | 7 days after NSAID TID administration, following vitrectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NSAIDs concentration (ng/mL) into the vitreous | 7 days after NSAID TID administration, following vitrectomy | Vitreous concentrations of the study drugs were quantified using a reverse phase high performance liquid chromatography mass spectroscopy system. |
| Adverse events | 7 days after NSAID TID administration, following vitrectomy | — |
Outcome results
None listed