University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224, United States
Location status: Recruiting
Location contact
Amy Monroe, MPH, MBA
CONTACT
Kanwal Nischal, MD,FRCOphth
PRINCIPAL_INVESTIGATOR
Lieu Tran, MD
SUB_INVESTIGATOR
NCT Number: NCT06275308
This study is to investigate the relationship between arterial carbon dioxide (CO2) concentration and vitreous pressure on the choroidal volume by integrated intraoperative OCT imaging under eye exams under anesthesia.
Interested in participating?
Request InfoUp to 8 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15224, United States
Location status: Recruiting
Amy Monroe, MPH, MBA
CONTACT
Kanwal Nischal, MD,FRCOphth
PRINCIPAL_INVESTIGATOR
Lieu Tran, MD
SUB_INVESTIGATOR
Children with normal eyes undergoing an exam under anesthesia or a non-intraocular eye procedure will have one eye examined after research consent is taken. Children have very elastic ocular tissues. When they are having an intraocular procedure positive vitreous pressure can cause the iris to prolapse out of the eye and this can cause intraoperative and postoperative complications. The causes of the positive vitreous pressure have been speculated to be due to an increase in choroidal volume. The Choroid is a layer of blood vessels sitting between the sclera and the retina. Ocular Coherence Tomography (OCT) is an imaging tool that allows an optical section of the retina, choroid and sclera to be examined. The subfoveal choroidal thickness has been shown to be a consistent area that can be measured with reliability that the anatomical site of measurement is consistent. By varying the end tidal CO2 the thickness of the choroid will be measured and at the same time the intraocular pressure taken using a pneumatonometer. The OCT is integrated into the operating microscope and is used to take a scan of the fovea. Three scans will be taken after 5minutes of the particular end tidal pCO2. In order to ensure the choroidal thickness is not being influenced by the axial length of the eye, the axial length will be measured using an ultrasound probe at the beginning of the measurements just once. In order to ensure that the position of the head and body is not influencing the choroidal thickness a spirit level will be used to ensure a flat operating bed at the beginning of the measurements.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Effects of ventilation manipulation to achieve desired levels of end tidal carbon dioxide
Time frame: 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
Measurement of intraocular pressure after maintenance of end tidal pCO2 for 5 minutes at three end tidal pCO2 values : 40mmHg, then 30mmHg and then 50mmHg
Time frame: 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
After 5 minutes of maintenance of end tidal pCO2 at 40mmHg, then 30mmHg and then 50mmHg, ocular coherence tomography (OCT) will be used to capture the subfoveal choroid. The images of the choroid will be provided to blinded individuals who will measure their thickness using the integrated scale on the OCT image.
Contact information is provided by the study sponsor or research team.
Alisha Maslanka, BS, CCRC
CONTACT
412-491-2748 ext. 2748
Amy Monroe, MPH, MBA
CONTACT
412-623-6382 ext. 6382
University of Pittsburgh
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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