NSAIDs and PGE2 Levels in Vitrectomy Patients

Università degli Studi di Brescia

Status and phase: Completed; Phase 3

Conditions: Vitreous Inflammation

Treatments: Drug: Bromfenac 0.09% eyedrops; Drug: Nepafenac 0.1% eyedrops; Drug: Indomethacin 0.5% eyedrops; Drug: Ketorolac 0.5% eyedrops

Study type: Interventional

Funder types: Other

Identifiers

NCT02361645

Vitreo001

Details and patient eligibility

About

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).

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with pucker scheduled for vitrectomy

Exclusion criteria

• diabetes
• active inflammation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 5 patient groups

Control Group

No Intervention group

Description:

No NSAIDs were administered prior to surgery

Ketorolac eyedrops

Experimental group

Description:

Ketorolac 0.5% eyedrops were administered prior to surgery

Treatment:

Drug: Ketorolac 0.5% eyedrops

Indomethacin eyedrops

Experimental group

Description:

Indomethacin 0.5% eyedrops were administered prior to surgery

Treatment:

Drug: Indomethacin 0.5% eyedrops

Nepafenac eyedrops

Experimental group

Description:

Nepafenac 0.1% eyedrops were administered prior to surgery

Treatment:

Drug: Nepafenac 0.1% eyedrops

Bromfenac eyedrops

Experimental group

Description:

Bromfenac 0.09% eyedrops were administered prior to surgery

Treatment:

Drug: Bromfenac 0.09% eyedrops