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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: Completed Early Phase 1 study, sponsored by University of Miami.
NCT01925391 is a Early Phase 1 study that has completed, run by University of Miami. The registered enrollment target is 75 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The investigator's intention is to measure IOP in children, who otherwise will be undergoing elective surgery, under nitrous oxide in oxygen and compare those measurements with those going under anesthesia with Sevoflurane in oxygen. The investigators hypothesize that children pre-sedated for surgery,cooperate with topical eye anesthetics and nitrous oxide in oxygen for IOP measurements and results may reflect pre-anesthetic baseline pressures when compared with an induction with Sevoflurane in
Interventions
- DRUG Tono-pen XL Applanation tonometer + Ocu-film +
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-05 |
| Phase | Early Phase 1 |
What the finished NCT01925391 record still lists
NCT01925391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (42% higher).
The record links to 0 conditions, and to 1 intervention - of which Tono-pen XL Applanation tonometer + Ocu-film + is the first listed.
NCT01925391 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01925391's enrollment target sits among peer trials
75 304th of 2000 higher than 1,690 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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