Investigating how carbon dioxide levels affect eye pressure in children
Effect of Raised End-Tidal pCo2 on Choroidal Volume
This study is testing how different levels of carbon dioxide in the body affect eye pressure in young children during eye exams.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | N/A to 8 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06275308 on ClinicalTrials.gov |
What this trial studies
This study examines the relationship between arterial carbon dioxide concentration and vitreous pressure on choroidal volume in children undergoing eye exams under anesthesia. Using integrated intraoperative OCT imaging, the thickness of the choroid will be measured while manipulating end-tidal CO2 levels. The goal is to understand how changes in CO2 levels may influence intraocular pressure and potentially lead to complications during eye procedures. Children aged newborn to 8 years with normal eyes will be included, and various measurements will be taken to ensure accuracy.
Who should consider this trial
Good fit: Ideal candidates are children aged newborn to 8 years undergoing an eye exam under anesthesia for ophthalmologic reasons.
Not a fit: Patients over the age of 8 or those with specific medical conditions affecting the eye or cerebral autoregulation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and outcomes for pediatric eye surgeries by minimizing complications related to intraocular pressure.
How similar studies have performed: While the specific approach of manipulating CO2 levels in this context may be novel, related studies have explored the effects of gas concentrations on ocular conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 with a known medical diagnosis that affect the eye to be studied * \* children over the age of 8 years of age. * \* children with altered cerebral autoregulation, increased intracranial pressure, pulmonary hypertension, or any other condition deemed appropriate by the anesthesiologist. * children in whom a laryngeal mask airway will not be used
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Kanwal Nischal, MD,FRCOphth — University of Pittsburgh
- Study coordinator: Amy Monroe, MPH, MBA
- Email: monroeal@upmc.edu
- Phone: 412-623-6382
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.