Skip to main content
OpenTrials
Completed

NCT Number: NCT01798966

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shiley Eye Center, University of California, San Diego

La Jolla, California, 92093-0496, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SENSIMED Triggerfish

Device

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sensimed AG

Industry

Collaborators

  • University of California, San Diego

Registry information

Official study 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®

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 26, 2013
Registry last updated
Mar 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.