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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06275308
Other study ID # STUDY21100163
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 27, 2023
Est. completion date February 27, 2025

Study information

Verified date February 2024
Source University of Pittsburgh
Contact Amy Monroe, MPH, MBA
Phone 412-623-6382
Email monroeal@upmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date February 27, 2025
Est. primary completion date February 27, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 8 Years
Eligibility Inclusion Criteria: - any child undergoing an eye exam under anesthesia for an ophthalmologic reason. - children between the ages newborn to 8 years of age. Exclusion Criteria: - children who are not having an eye exam under anesthesia. - * children over the age of 8 years of age. - * children with altered cerebral autoregulation, or increased intracranial pressure, or any other condition deemed appropriate by the anesthesiologist.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Ventilation manipulation
Effects of ventilation manipulation to achieve desired levels of end tidal carbon dioxide

Locations

Country Name City State
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intraocular Pressure (IOP) (mmHg) 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 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
Secondary Choroidal thickness ( microns) 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. 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
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