Clinical trial NCT01798966: Twenty-four Hour Intraocular Pressure Patterns in Patients With Uncontrolled Thyroid Eye Disease
Official title: 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®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Eye Disease
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Diego
First posted: 2013-02-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Subject is able to comply with the study procedures
* 18-80 years old
* Subjects diagnosed with Thyroid Eye Disease based on both endocrinology studies showing autoimmune dysfunction consistent with Graves' Disease as well as orbital imaging studies manifesting characteristics consistent with Thyroid Eye Disease.
* Ability to understand the character and individual consequences of the study
* Subject has consented to be in the trial

Exclusion Criteria:

* Subjects with contraindications for wearing contact lenses
* Severe ocular surface disease
* Keratoconus or other corneal abnormality
* Severe ocular inflammation
* Full frame metal glasses during SENSIMED Triggerfish® monitoring
* Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine)
* Simultaneous participation in other clinical studies
* Diagnosis of glaucoma

Primary outcomes:
measure: Change in IOP Before and After Orbital Decompression Surgery
timeFrame: 24 hours
Secondary outcomes:
measure: IOP Patterns
timeFrame: 24 hours
Other outcomes:
measure: Adverse Events and Serious Adverse Events
timeFrame: 4 days
Locations:
city: La Jolla
country: United States
facility: Shiley Eye Center, University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Donald O Kikkawa, MD
role: PRINCIPAL_INVESTIGATOR
References: