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

Not Applicable

Completed

• Conditions: Thyroid Eye Disease
• Interventions: Device: SENSIMED Triggerfish

• Registration Number: NCT01798966
• Lead Sponsor: Sensimed AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-21
• Study First Submitted QC: 2013-02-22
• Study First Posted: 2013-02-26
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2014-12-04
• Results First Submitted QC: 2015-02-20
• Results First Posted: 2015-03-02
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-15
• Last Update Posted: 2016-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SENSIMED Triggerfish	SENSIMED Triggerfish	Sensimed Triggerfish device will be worn by each subject for 24h

Primary Outcome Measures

Name	Time	Method
Change in IOP Before and After Orbital Decompression Surgery	24 hours	To investigate the difference in SENSIMED Triggerfish output during transition from wake to sleep states before and after orbital decompression

Secondary Outcome Measures

Name	Time	Method
IOP Patterns	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

Trial Locations

Locations (1)

Shiley Eye Center, University of California, San Diego; 🇺🇸 La Jolla, California, United States