NSAIDs and PGE2 Levels in Vitrectomy Patients

Phase 3

Completed

• Conditions: Vitreous Inflammation
• Interventions: Drug: Indomethacin 0.5% eyedrops; Drug: Nepafenac 0.1% eyedrops; Drug: Bromfenac 0.09% eyedrops; Drug: Ketorolac 0.5% eyedrops

• Registration Number: NCT02361645
• Lead Sponsor: Università degli Studi di Brescia

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2014-11
• Study Completion: 2015-01
• Study First Submitted: 2015-01-27
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-06
• Last Update Submitted: 2015-02-06
• Study First Posted: 2015-02-12
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• patients with pucker scheduled for vitrectomy

Exclusion Criteria

• diabetes
• active inflammation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indomethacin eyedrops	Indomethacin 0.5% eyedrops	Indomethacin 0.5% eyedrops were administered prior to surgery
Nepafenac eyedrops	Nepafenac 0.1% eyedrops	Nepafenac 0.1% eyedrops were administered prior to surgery
Bromfenac eyedrops	Bromfenac 0.09% eyedrops	Bromfenac 0.09% eyedrops were administered prior to surgery
Ketorolac eyedrops	Ketorolac 0.5% eyedrops	Ketorolac 0.5% eyedrops were administered prior to surgery

Primary Outcome Measures

Name	Time	Method
Prostaglandin E2 levels in the vitreous (pg/mL)	7 days after NSAID TID administration, following vitrectomy

Secondary Outcome Measures

Name	Time	Method
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