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Ventilation Manipulation for Glaucoma

N/A
Recruiting
Led By Kanwal Nischal, MD,FRCOphth
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any child undergoing an eye exam under anesthesia for an ophthalmologic reason
Children between the ages newborn to 8 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after induction of anesthesia end tidal co2 will be manipulated to 40mmhg, then 30mmhg and then 50mmhg. the end tidal co2 levels will be held for at least 5 minutes after each ventilation manipulation;at the end of 5 minute period choroid images taken
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study how the amount of carbon dioxide in the blood and the pressure inside the eye affect the volume of a specific part of the eye using a special imaging technique during eye exams done while

Who is the study for?
This clinical trial is for children from newborns up to 8 years old who are already scheduled for an eye exam under anesthesia due to ophthalmologic reasons. It's not suitable for kids over 8, those with conditions affecting brain blood flow regulation, increased pressure inside the skull, or any issues the anesthesiologist thinks could cause problems.
What is being tested?
The study is examining how changing the amount of carbon dioxide (CO2) in a child's breath affects the thickness of part of their eye called the choroid. This will be done using special imaging during an eye exam while they're under anesthesia.
What are the potential side effects?
Since this trial involves ventilation manipulation rather than medication, side effects may include discomfort from changes in breathing patterns and potential risks associated with general anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child needs an eye exam under anesthesia for an eye condition.
Select...
My child is between newborn and 8 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after induction of anesthesia end tidal co2 will be manipulated to 40mmhg, then 30mmhg and then 50mmhg. the end tidal co2 levels will be held for at least 5 minutes after each ventilation manipulation and at the end of this 5 minute period iop measured
This trial's timeline: 3 weeks for screening, Varies for treatment, and after induction of anesthesia end tidal co2 will be manipulated to 40mmhg, then 30mmhg and then 50mmhg. the end tidal co2 levels will be held for at least 5 minutes after each ventilation manipulation and at the end of this 5 minute period iop measured for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Intraocular Pressure (IOP) (mmHg)
Secondary study objectives
Choroidal thickness ( microns)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Observational GroupExperimental Treatment1 Intervention
Manipulation of end tidal carbon dioxide in subjects

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,792 Previous Clinical Trials
16,359,966 Total Patients Enrolled
7 Trials studying Glaucoma
11,145 Patients Enrolled for Glaucoma
Amy Monroe, MPH, MBAStudy DirectorUniversity of Pittsburgh
4 Previous Clinical Trials
1,755 Total Patients Enrolled
Kanwal Nischal, MD,FRCOphthPrincipal InvestigatorUniversity of Pittsburgh
~2 spots leftby Feb 2025