Twenty-four Hour Intraocular Pressure Patterns in Patients With Uncontrolled Thyroid Eye Disease



Status:Completed
Conditions:Ocular, Endocrine
Therapuetic Areas:Endocrinology, Ophthalmology
Healthy:No
Age Range:18 - 90
Updated:4/21/2016
Start Date:February 2013
End Date:June 2013

Use our guide to learn which trials are right for you!

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®

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.


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
We found this trial at
1
site
?
mi
from
La Jolla, CA
Click here to add this to my saved trials