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

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ClinicalTrials.gov Identifier: NCT01798966
Recruitment Status : Completed
First Posted : February 26, 2013
Results First Posted : March 2, 2015
Last Update Posted : March 11, 2016
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Sensimed AG

Study Description
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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.

Condition or disease Intervention/treatment Phase
Thyroid Eye Disease Device: SENSIMED Triggerfish Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : February 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: SENSIMED Triggerfish
Sensimed Triggerfish device will be worn by each subject for 24h
 Device: SENSIMED Triggerfish
Other Name: Contact lens sensor intented to continuously record IOP pattern for up to 24 hours


Outcome Measures
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Primary Outcome Measures :
  1. Change in IOP Before and After Orbital Decompression Surgery [ Time Frame: 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 :
  1. IOP Patterns [ Time Frame: 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


Other Outcome Measures:
  1. Adverse Events and Serious Adverse Events [ Time Frame: 4 days ]
    Safety will be evaluated throughout the duration of the study by collecting all adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798966


Locations
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United States, California
Shiley Eye Center, University of California, San Diego
La Jolla, California, United States, 92093-0496
Sponsors and Collaborators
Sensimed AG
University of California, San Diego
Investigators
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Principal Investigator: Donald O Kikkawa, MD University of California, San Diego
More Information
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Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01798966    
Other Study ID Numbers: TF-1111
First Posted: February 26, 2013    Key Record Dates
Results First Posted: March 2, 2015
Last Update Posted: March 11, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Eye Diseases
Graves Ophthalmopathy
Thyroid Diseases
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
 Orbital Diseases
Genetic Diseases, Inborn
Goiter
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases