NCT01925391

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 16, 2014

Status Verified

June 1, 2014

Enrollment Period

1.3 years

First QC Date

August 12, 2013

Last Update Submit

June 13, 2014

Conditions

GlaucomaIntraocular PressureAnesthesia

Keywords

Pediatric glaucomaIntraocular pressurepediatric glaucoma diagnosisVolatiles and intraocular pressurenitrous oxideTetracaine

Outcome Measures

Primary Outcomes (1)

  • Measurement of intraocular pressure in nonglaucomatous children under Nitrous oxide/Oxygen/topical anesthesia and Nitrous oxide/Sevoflurane/oxygen/Topical anesthesia.

    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 oxygen.

    Up to 40 weeks

Study Arms (2)

Sevoflurane, oxygen, intraocular pressure

ACTIVE COMPARATOR

Intraocular measurements under induction with Sevoflurane in oxygen

Drug: Tono-pen XL Applanation tonometer + Ocu-film +

Nitrous oxide/O2/tetracaine

ACTIVE COMPARATOR

intraocular pressures in children undergoing inhalation induction with nitrous oxide in oxygen

Drug: Tono-pen XL Applanation tonometer + Ocu-film +

Interventions

Tono-pen XL Applanation tonometer + Ocu-film +DRUG
Also known as: Tono-pen Applanation tonometer, Reichert Technologies
Nitrous oxide/O2/tetracaineSevoflurane, oxygen, intraocular pressure

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Miami Bascom Palmer Eye Hospital

Miami, Florida, 33125, United States

Location

Bascom Palmer Eye Hospital

Miami, Florida, 33138, United States

Location

MeSH Terms

Conditions

GlaucomaHydrophthalmos

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesEye AbnormalitiesGlaucoma, Open-AngleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Jacqueline L tutiven, Md

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Clinical Anesthesia

Study Record Dates

First Submitted

August 12, 2013

First Posted

August 19, 2013

Study Start

January 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 16, 2014

Record last verified: 2014-06

Locations

US(2)