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

Primary Purpose

Thyroid Eye Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SENSIMED Triggerfish
Sponsored by
Sensimed AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Eye Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shiley Eye Center, University of California, San Diego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SENSIMED Triggerfish

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 21, 2013
Last Updated
February 15, 2016
Sponsor
Sensimed AG
Collaborators
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01798966
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sensimed AG
Collaborators
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Eye Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SENSIMED Triggerfish
Arm Type
Experimental
Arm Description
Sensimed Triggerfish device will be worn by each subject for 24h
Intervention Type
Device
Intervention Name(s)
SENSIMED Triggerfish
Other Intervention Name(s)
Contact lens sensor intented to continuously record IOP pattern for up to 24 hours
Primary Outcome Measure Information:
Title
Change in IOP Before and After Orbital Decompression Surgery
Description
To investigate the difference in SENSIMED Triggerfish output during transition from wake to sleep states before and after orbital decompression
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
IOP Patterns
Description
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
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Adverse Events and Serious Adverse Events
Description
Safety will be evaluated throughout the duration of the study by collecting all adverse events
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald O Kikkawa, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shiley Eye Center, University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0496
Country
United States

12. IPD Sharing Statement

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

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