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Completed

NCT Number: NCT03597867

PGE2 Levels in Patient Treated With NSAIDs

The aim of this study is to determine vitreous levels of nonsteroidal antinflammatory drugs (NSAIDs) and prostaglandinE2 (PGE2) in eyes scheduled for vitrectomy.

All patients received the study drugs for 3 days before surgery. 0.5 to 1.0 mL of undiluted vitreous was removed using the vitreous cutter positioned in the midvitreous cavity. Samples were immediately frozen and stored at -80°C until analysis.

Sample analyses were performed using an high-performance liquid chromatography system. The lower limit of quantitation was 0.8 ng/mL.

PGE2 levels were analyzed using the Prostaglandin E2 Monoclonal EIA Kit (Cayman Chemical Company) according to the manufacturer's instructions.

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Key information

Conditions

Ocular Inflammation Epiretinal Membrane Eye Diseases Retinal Diseases Retinal Perforations

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste

Trieste, TS, 34129, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • epiretinal membrane or full thickness macular hole scheduled for vitrectomy

Exclusion criteria

  • vitreous hemorrhage
  • diabetes
  • glaucoma
  • concurrent retinovascular disease
  • previous ocular inflammation
  • previous ocular surgery
  • history of ocular trauma
  • previuos intravitreal injections
  • concomitant intake of topical or systemic NSAIDs or corticosteroid therapy

Treatment and study plan

Placebo

Other

Artificial tears for 3 days preoperatively

Other names: Tears

Dicloftil

Drug

Dosing of drug 3 days prior to surgery

Other names: Diclofenac Na 0.1% Oph Soln

Nevanac

Drug

Dosing of drug 3 days prior to surgery

Other names: Nepafenac 0.3% Ophthalmic Suspension

Indom

Drug

Dosing of drug 3 days prior to surgery

Other names: Indomethacin 5 MG/ML Ophthalmic Suspension

Yellox

Drug

Dosing of drug 3 days prior to surgery

Other names: Bromfenac 0.09 % Ophthalmic Solution

Primary outcomes

  1. Vitreous NSAIDs and PGE2 levels

    Time frame: 3 days after topical NSAID administration

Sponsors and collaborators

Lead sponsor

University of Trieste

Other

Registry information

Official study title

Vitreous pge2 Level Changes After Topical Administration of Diclofenac 0.1%, Nepafenac 0.3%, Indomethacin 0.5% and Bromfenac 0.09% in Vitrectomy Patients

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2018
Registry last updated
Jul 24, 2018

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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