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

Completed · Early Phase 1

Conditions studied: Glaucoma, Intraocular Pressure, Anesthesia

In brief

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.

Key facts

Study ID

NCT01925391

Run by

University of Miami

People needed

75

Starts

2013-01-01

Expected to finish

2014-05-01

Last updated by the study team

2014-06-16

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• male or female from 1 year of age to less than 18 years of age
• Out-patients scheduled to undergo examination under anesthesia
• out-patients scheduled to undergo eye surgery for strabismus or oculoplastic procedure.
• ASA status I or II
• female patients who have attained menarche must have negative pregnancy tests at screening

You may not qualify if…

• patients that have contraindications to the use of nitrous oxide in oxygen
• glaucoma patients
• patients in whom IOP cannot be measured accurately
• latex allergy patients
• patients allergic to aminoesthers

Where it is running

• University of Miami Bascom Palmer Eye Hospital — Miami, Florida, United States
• Bascom Palmer Eye Hospital — Miami, Florida, United States

Full record on ClinicalTrials.gov

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