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

• Sponsor: Sensimed AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01798966
• Collaborator: University of California, San Diego (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 3.9
• Patients Per Site Per Month: 2.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Eye Disease	Device: SENSIMED Triggerfish	N/A

Study Design

• Study Type: Interventional
• 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: Feb 1, 2013
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SENSIMED Triggerfish Sensimed Triggerfish device will be worn by each subject for 24h	Device: SENSIMED Triggerfish; Other Names: Contact lens sensor intented to continuously record IOP pattern for up to 24 hours

Outcome Measures

Primary Outcome Measures

1. Change in IOP Before and After Orbital Decompression Surgery [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 [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 [4 days]

   Safety will be evaluated throughout the duration of the study by collecting all adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sensimed AG
• ClinicalTrials.gov Identifier: NCT01798966
• Other Study ID Numbers: TF-1111
• First Posted: Feb 26, 2013
• Last Update Posted: Mar 11, 2016
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Eye Diseases; Graves Ophthalmopathy; Thyroid Diseases

Study Results

Participant Flow

Arm/Group Title	SENSIMED Triggerfish
Arm/Group Description	All patients included in the device group
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	SENSIMED Triggerfish
Arm/Group Description	All patients included in the device group
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.8 (21.6)
Sex: Female, Male (Count of Participants)
Female	9 90%
Male	1 10%
Region of Enrollment (participants) [Number]
United States	10 100%
Tolerability of CLS (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.5 (0.7)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SENSIMED Triggerfish
Arm/Group Description	SENSIMED Triggerfish worn for 24h
Measure Participants	10
Median (Standard Deviation) [mVEq (Sensismed Triggerfish output unit)]	18 (43.8)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SENSIMED Triggerfish
Arm/Group Description	All patients included in the device group
Measure Participants	10
Mean (Standard Deviation) [mvEq]	102.2 (52.6)

3. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SENSIMED Triggerfish
Arm/Group Description	SENSIMED Triggerfish worn for 24h
Measure Participants	10
Number [Number of AE]	3

Adverse Events

Time Frame	From inform consent signature to 30 days after last exposure to device
Arm/Group Title	SENSIMED Triggerfish
Arm/Group Description	All patients included in the device group
All Cause Mortality
	SENSIMED Triggerfish
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	SENSIMED Triggerfish
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	SENSIMED Triggerfish
	Affected / at Risk (%)	# Events
Total	10/10 (100%)
Eye disorders
Mild blurred vision	5/10 (50%)
Mild hyperemia and palpebral conjunctiva	10/10 (100%)
Superficial Punctate keratitis	2/10 (20%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.