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

NCT ID: NCT01798966

Last Updated: 2016-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-06-30

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.

Conditions

Thyroid Eye Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

SENSIMED Triggerfish

Sensimed Triggerfish device will be worn by each subject for 24h

Group Type: EXPERIMENTAL

SENSIMED Triggerfish

Intervention Type: DEVICE

Interventions

SENSIMED Triggerfish

Intervention Type: DEVICE

Other Intervention Names

Contact lens sensor intented to continuously record IOP pattern for up to 24 hours

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

Sensimed AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donald O Kikkawa, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Shiley Eye Center, University of California, San Diego

La Jolla, California, United States

Countries

United States

Other Identifiers

TF-1111

Identifier Type: -

Identifier Source: org_study_id