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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo using single-use vials of hyaluronic acid 0.2% preservative-free lubricating tear drops three days before surgery. |
|
| Dicloftil | Experimental | Diclofenac Na 0.1% Oph Soln, "Dicloftil®", NSAID eyedrops administered three days before surgery |
|
| Nevanac | Experimental | Nepafenac 0.3% Ophthalmic Suspension, "Nevanac 3mg/ml®", NSAID eyedrops administered three days before surgery |
|
| Indom | Experimental | Indomethacin 5 MG/ML Ophthalmic Suspension, "Indom ®", NSAID eyedrops administered three days before surgery |
|
| Yellox | Experimental | Bromfenac 0.09 % Ophthalmic Solution, "Yellox®", NSAID eyedrops administered three days before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Artificial tears for 3 days preoperatively |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Vitreous NSAIDs and PGE2 levels | 3 days after topical NSAID administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco R Pastore, MD | Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste Trieste, TS, 34129, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste | Trieste | TS | 34129 | Italy |
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| ID | Term |
|---|---|
| D019773 | Epiretinal Membrane |
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C414203 | nepafenac |
| D007213 | Indomethacin |
| C053083 | bromfenac |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Dicloftil | Drug | Dosing of drug 3 days prior to surgery |
|
|
| Nevanac | Drug | Dosing of drug 3 days prior to surgery |
|
|
| Indom | Drug | Dosing of drug 3 days prior to surgery |
|
|
| Yellox | Drug | Dosing of drug 3 days prior to surgery |
|
|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |