PGE2 Levels in Patient Treated With NSAIDs

Study Overview
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Brief Summary
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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.

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

Conditions
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Ocular Inflammation

Intervention / Treatment
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* Other: Placebo
* Drug: Dicloftil
* Drug: Nevanac
* Drug: Indom
* Drug: Yellox


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo using single-use vials of hyaluronic acid 0.2% preservative-free lubricating tear drops three days before surgery. | Other: Placebo<br>* Artificial tears for 3 days preoperatively<br>* Other names: Tears;|
| Experimental: Dicloftil<br>Diclofenac Na 0.1% Oph Soln, Dicloftil®, NSAID eyedrops administered three days before surgery | Drug: Dicloftil<br>* Dosing of drug 3 days prior to surgery<br>* Other names: Diclofenac Na 0.1% Oph Soln;|
| Experimental: Nevanac<br>Nepafenac 0.3% Ophthalmic Suspension, Nevanac 3mg/ml®, NSAID eyedrops administered three days before surgery | Drug: Nevanac<br>* Dosing of drug 3 days prior to surgery<br>* Other names: Nepafenac 0.3% Ophthalmic Suspension;|
| Experimental: Indom<br>Indomethacin 5 MG/ML Ophthalmic Suspension, Indom ®, NSAID eyedrops administered three days before surgery | Drug: Indom<br>* Dosing of drug 3 days prior to surgery<br>* Other names: Indomethacin 5 MG/ML Ophthalmic Suspension;|
| Experimental: Yellox<br>Bromfenac 0.09 % Ophthalmic Solution, Yellox®, NSAID eyedrops administered three days before surgery | Drug: Yellox<br>* Dosing of drug 3 days prior to surgery<br>* Other names: Bromfenac 0.09 % Ophthalmic Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitreous NSAIDs and PGE2 levels |  | 3 days after topical NSAID administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitreoretinal surgery, epiretinal membrane, macular hole, non steroidal antinflammatory drugs, prostaglandin E2