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

This study has been completed.
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Sensimed AG
ClinicalTrials.gov Identifier:
NCT01798966
First received: February 21, 2013
Last updated: December 5, 2013
Last verified: February 2013
  Purpose

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 Intervention
Thyroid Eye Disease
Device: SENSIMED Triggerfish

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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®

Resource links provided by NLM:


Further study details as provided by Sensimed AG:

Primary Outcome Measures:
  • Change in IOP before and after orbital decompression surgery in patients with TED using the SENSIMED Triggerfish® 24-hour IOP monitoring contact lens [ Time Frame: within 24 hours ] [ Designated as safety issue: No ]
    To investigate the difference in SENSIMED Triggerfish output during transition from wake to sleep states


Secondary Outcome Measures:
  • IOP patterns [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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:
  • Adverse events and Serious adverse events [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
    Safety will be evaluated throughout the duration of the study by collecting all adverse events


Estimated Enrollment: 10
Study Start Date: February 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SENSIMED Triggerfish Device: SENSIMED Triggerfish
Other Name: Contact lens sensor intented to continuously record IOP pattern for up to 24 hours

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01798966

Locations
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
Principal Investigator: Donald O Kikkawa, MD University of California, San Diego
  More Information

No publications provided

Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01798966     History of Changes
Other Study ID Numbers: TF-1111
Study First Received: February 21, 2013
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Eye Diseases
Thyroid Diseases
Graves Ophthalmopathy
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Goiter
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014