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NCT01925391 · ClinicalTrials.gov registry record · Early Phase 1

The Measurement of Intraocular Pressure in Normal Children Under General Anesthesia With and Without Nitrous Oxide and Anesthetic Eye Drops

A Early Phase 1 study, sponsored by University of Miami.

Completed
Registry status
Early Phase 1
Development phase
75
Enrollment target

NCT01925391 is a Early Phase 1 study that has completed, run by University of Miami. The registered enrollment target is 75 participants.

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The verdict

NCT01925391, a Early Phase 1 study, has completed, sponsored by University of Miami.

COMPLETED
Registry status
Early Phase 1
Development phase
75 participants
Enrollment target

Study Summary

Pediatric glaucoma is a rare but potentially blinding condition where the pressure in the eye is too high. Diagnosis is based on intraocular pressure (IOP) and assessment of the optic nerve, cornea and other structures. Accurate intraocular pressure measurements in young children is often impossible to obtain in an office setting. Children need sedation or general anesthesia to determine IOP. All volatile general anesthetics affect the IOP. Nitrous Oxide, a weak volatile anesthetic, does not affect IOP in healthy adults. Since Nitrous Oxide has shown to be safe and effective in a variety of practice environments, we want to evaluate the use of nitrous oxide in oxygen to obtain IOP measurements in children.

Interventions

  • DRUG Tono-pen XL Applanation tonometer + Ocu-film +

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2013-01
Est. Completion 2014-05
Phase Early Phase 1

Sponsor

University of Miami

721 total trials

What the Registry Record Tells You About NCT01925391

The ClinicalTrials.gov registry entry for NCT01925391 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Tono-pen XL Applanation tonometer + Ocu-film + is the first listed.

NCT01925391 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01925391 about?

NCT01925391 is a clinical study titled "The Measurement of Intraocular Pressure in Normal Children Under General Anesthesia With and Without Nitrous Oxide and Anesthetic Eye Drops". Pediatric glaucoma is a rare but potentially blinding condition where the pressure in the eye is too high. Diagnosis is based on intraocular pressure (IOP) and assessment of the optic nerve, cornea and other structures. Accurate intraocular pressure measurements in young children is often impossible...

What is the current status of trial NCT01925391?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 75 participants. The study started on 2013-01. Estimated completion is 2014-05.

What interventions are being tested in trial NCT01925391?

The interventions under investigation include: Tono-pen XL Applanation tonometer + Ocu-film + (DRUG).

Who is sponsoring clinical trial NCT01925391?

This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.