Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
70 participants
INTERVENTIONAL
2014-03-31
2015-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control Group
No NSAIDs were administered prior to surgery
No interventions assigned to this group
Ketorolac eyedrops
Ketorolac 0.5% eyedrops were administered prior to surgery
Ketorolac 0.5% eyedrops
Indomethacin eyedrops
Indomethacin 0.5% eyedrops were administered prior to surgery
Indomethacin 0.5% eyedrops
Nepafenac eyedrops
Nepafenac 0.1% eyedrops were administered prior to surgery
Nepafenac 0.1% eyedrops
Bromfenac eyedrops
Bromfenac 0.09% eyedrops were administered prior to surgery
Bromfenac 0.09% eyedrops
Interventions
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Ketorolac 0.5% eyedrops
Indomethacin 0.5% eyedrops
Bromfenac 0.09% eyedrops
Nepafenac 0.1% eyedrops
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* active inflammation
18 Years
ALL
No
Sponsors
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Università degli Studi di Brescia
OTHER
Responsible Party
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Andrea Russo
PhD Candidate
References
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Morescalchi F, Russo A, Semeraro F. SURGICAL OUTCOMES OF VITREOMACULAR TRACTION TREATED WITH FOVEAL-SPARING PEELING OF THE INTERNAL LIMITING MEMBRANE. Retina. 2021 Oct 1;41(10):2026-2034. doi: 10.1097/IAE.0000000000003139.
Other Identifiers
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Vitreo001
Identifier Type: -
Identifier Source: org_study_id
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