NSAIDs and PGE2 Levels in Vitrectomy Patients

Study Overview
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Brief Summary
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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).

Official Title
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Vitreous Nonsteroidal Antiinflammatory Drus Concentrations And Prostaglandin E2 Levels in Vitrectomy Patients Treated With Indomethacin 0.5%, Bromfenac 0.09%, and Nepafenac 0.1%

Conditions
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Vitreous Inflammation

Intervention / Treatment
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* Drug: Ketorolac 0.5% eyedrops
* Drug: Indomethacin 0.5% eyedrops
* Drug: Bromfenac 0.09% eyedrops
* Drug: Nepafenac 0.1% eyedrops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with pucker scheduled for vitrectomy Exclusion Criteria: diabetes active inflammation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| No Intervention: Control Group<br>No NSAIDs were administered prior to surgery | |
| Experimental: Ketorolac eyedrops<br>Ketorolac 0.5% eyedrops were administered prior to surgery | Drug: Ketorolac 0.5% eyedrops<br> <br> |
| Experimental: Indomethacin eyedrops<br>Indomethacin 0.5% eyedrops were administered prior to surgery | Drug: Indomethacin 0.5% eyedrops<br> <br> |
| Experimental: Nepafenac eyedrops<br>Nepafenac 0.1% eyedrops were administered prior to surgery | Drug: Nepafenac 0.1% eyedrops<br> <br> |
| Experimental: Bromfenac eyedrops<br>Bromfenac 0.09% eyedrops were administered prior to surgery | Drug: Bromfenac 0.09% eyedrops<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostaglandin E2 levels in the vitreous (pg/mL) |  | 7 days after NSAID TID administration, following vitrectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NSAIDs concentration (ng/mL) into the vitreous | Vitreous concentrations of the study drugs were quantified using a reverse phase high performance liquid chromatography mass spectroscopy system. | 7 days after NSAID TID administration, following vitrectomy | 
| Adverse events |  | 7 days after NSAID TID administration, following vitrectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nonsteroidal antiinflammatory drugs, prostaglandin E2, vitrectomy