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OpenTrials
Completed

NCT Number: NCT02361645

NSAIDs and PGE2 Levels in Vitrectomy Patients

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).

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Key information

Conditions

Vitreous Inflammation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with pucker scheduled for vitrectomy

Exclusion criteria

  • diabetes
  • active inflammation

Treatment and study plan

Ketorolac 0.5% eyedrops

Drug

Indomethacin 0.5% eyedrops

Drug

Bromfenac 0.09% eyedrops

Drug

Nepafenac 0.1% eyedrops

Drug

Primary outcomes

  1. Prostaglandin E2 levels in the vitreous (pg/mL)

    Time frame: 7 days after NSAID TID administration, following vitrectomy

Secondary outcomes

  1. NSAIDs concentration (ng/mL) into the vitreous

    Time frame: 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.

  2. Adverse events

    Time frame: 7 days after NSAID TID administration, following vitrectomy

Sponsors and collaborators

Lead sponsor

Università degli Studi di Brescia

Other

Registry information

Official study 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%

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Feb 12, 2015
Registry last updated
Feb 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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