NSAIDs and PGE2 Levels in Vitrectomy Patients

NCT ID: NCT02361645

Last Updated: 2015-02-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-01-31

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).

Detailed Description

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Conditions

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Vitreous Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control Group

No NSAIDs were administered prior to surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Ketorolac eyedrops

Ketorolac 0.5% eyedrops were administered prior to surgery

Group Type EXPERIMENTAL

Ketorolac 0.5% eyedrops

Intervention Type DRUG

Indomethacin eyedrops

Indomethacin 0.5% eyedrops were administered prior to surgery

Group Type EXPERIMENTAL

Indomethacin 0.5% eyedrops

Intervention Type DRUG

Nepafenac eyedrops

Nepafenac 0.1% eyedrops were administered prior to surgery

Group Type EXPERIMENTAL

Nepafenac 0.1% eyedrops

Intervention Type DRUG

Bromfenac eyedrops

Bromfenac 0.09% eyedrops were administered prior to surgery

Group Type EXPERIMENTAL

Bromfenac 0.09% eyedrops

Intervention Type DRUG

Interventions

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Ketorolac 0.5% eyedrops

Intervention Type DRUG

Indomethacin 0.5% eyedrops

Intervention Type DRUG

Bromfenac 0.09% eyedrops

Intervention Type DRUG

Nepafenac 0.1% eyedrops

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with pucker scheduled for vitrectomy

Exclusion Criteria

* diabetes
* active inflammation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Brescia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Russo

PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

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.

Reference Type DERIVED
PMID: 33595256 (View on PubMed)

Other Identifiers

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Vitreo001

Identifier Type: -

Identifier Source: org_study_id

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