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

Thyroid Eye Disease Clinical Trial

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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798966
• Other study ID #: TF-1111
• Status: Completed
• Phase: N/A
• First received: February 21, 2013
• Last updated: February 15, 2016
• Start date: February 2013
• Est. completion date: June 2013

Study information

• Verified date: February 2016
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Diseases
• Thyroid Eye Disease

Intervention

Device:
• SENSIMED Triggerfish

Locations

Country	Name	City	State
United States	Shiley Eye Center, University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Sensimed AG	University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events and Serious Adverse Events	Safety will be evaluated throughout the duration of the study by collecting all adverse events	4 days	Yes
Primary	Change in IOP Before and After Orbital Decompression Surgery	To investigate the difference in SENSIMED Triggerfish output during transition from wake to sleep states before and after orbital decompression	24 hours	No
Secondary	IOP Patterns	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	24 hours	No