Shiley Eye Center, University of California, San Diego
La Jolla, California, 92093-0496, United States
NCT Number: NCT01798966
Patients with Thyroid Eye Disease (TED) often have enlarged extraocular muscles and higher orbital fat contents due to their disease process. The confined space of the orbit cannot hold the enlarged orbital contents creating a forward displacement and/or compression of the globe with a rise in intraocular pressure (IOP). Many of these patients undergo surgical decompression, a procedure that fractures orbital bones, in order to allow more space for the enlarged orbital contents to occupy. To date, there is no data that shows intraocular patterns over a 24-hour period in patients with mechanical compression on the globe as in TED. It is not know if the pattern of IOP is more consistent with normal IOP patterns, glaucomatous patterns, or perhaps completely different then either. The goal of this project is to investigate patterns of IOP in patients requiring orbital decompression because of orbital congestion. Changes in IOP during a 24-hour period will be studied with a contact-lens embedded sensor that provides continuous data. This device has previously been investigated and shown to be safe and well-tolerated. Monitoring the pattern in these patients will allow us to compare Thyroid TED patterns of IOP with those of normal and glaucomatous patients. Also, testing these patients before and after orbital decompression surgery will allow characterization of how intraocular pressure changes once the mechanical compression on the globe is relieved.
Looking for future studies?
Notify Me18 year–90 year
All sexes
Interventional
Not applicable
La Jolla, California, 92093-0496, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Contact lens sensor intented to continuously record IOP pattern for up to 24 hours
Time frame: 24 hours
To investigate the difference in SENSIMED Triggerfish output during transition from wake to sleep states before and after orbital decompression
Time frame: 24 hours
The pattern of IOP in patients with TED will be compared with the pattern of IOP readings in normal subjects as well as glaucomatous patients
Time frame: 4 days
Safety will be evaluated throughout the duration of the study by collecting all adverse events
Sensimed AG
Industry
The Effects of Orbital Decompression Surgery on Intraocular Pressure Patterns in Patient With Thyroid Eye Disease Undergoing 24 Hour Continuous IOP Monitoring With the SENSIMED Triggerfish®
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT07155668
Autoimmune Diseases, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Inglewood, California, United States
View Trial DetailsNCT06367517
Autoimmune Diseases, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Warsaw, Poland
View Trial DetailsNCT06384547
Autoimmune Diseases, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Inglewood, California, United States
View Trial DetailsNCT06179875
Autoimmune Diseases, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Los Angeles, California, United States
View Trial Details