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

NCT01798966 | Completed Results

• 1 other identifier: TF-1111
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Secondary Outcomes (1)

• IOP Patterns

  24 hours

Other Outcomes (1)

• Adverse Events and Serious Adverse Events

  4 days

Study Arms (1)

SENSIMED Triggerfish

EXPERIMENTAL

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

Device: SENSIMED Triggerfish

Interventions

SENSIMED Triggerfish DEVICE

Also known as: Contact lens sensor intented to continuously record IOP pattern for up to 24 hours

SENSIMED Triggerfish

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is able to comply with the study procedures
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sensimed AG: lead
• University of California, San Diego: collaborator

Study Sites (1)

Shiley Eye Center, University of California, San Diego

La Jolla, California, 92093-0496, United States

Location

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Anjali Parekh
• Organization: Hamilton Glaucoma center

anjalism@gmail.com

+1858 822-1553

Study Officials

• Donald O Kikkawa, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2013
• First Posted: February 26, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 11, 2016
• Results First Posted: March 2, 2015

Record last verified: 2016-02

Locations

US (1)