Thyroid Eye Disease
Conditions
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.
Interventions
DEVICESENSIMED Triggerfish
Sponsors
University of California, San Diego
Sensimed AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events and Serious Adverse Events | 4 days | Safety will be evaluated throughout the duration of the study by collecting all adverse events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SENSIMED Triggerfish All patients included in the device group | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | SENSIMED Triggerfish |
|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 21.6 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 1 Participants |
| Tolerability of CLS | 1.5 units on a scale STANDARD_DEVIATION 0.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| SENSIMED Triggerfish | Change in IOP Before and After Orbital Decompression Surgery | 18 mVEq (Sensismed Triggerfish output unit) | Standard Deviation 43.8 |
Secondary
IOP Patterns
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SENSIMED Triggerfish | IOP Patterns | 102.2 mvEq | Standard Deviation 52.6 |
Other Pre-specified
Adverse Events and Serious Adverse Events
Safety will be evaluated throughout the duration of the study by collecting all adverse events
Time frame: 4 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SENSIMED Triggerfish | Adverse Events and Serious Adverse Events | 3 Number of AE |