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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SENSIMED Triggerfish | Experimental | Sensimed Triggerfish device will be worn by each subject for 24h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SENSIMED Triggerfish | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events and Serious Adverse Events | Safety will be evaluated throughout the duration of the study by collecting all adverse events | 4 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald O Kikkawa, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shiley Eye Center, University of California, San Diego | La Jolla | California | 92093-0496 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SENSIMED Triggerfish | All patients included in the device group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SENSIMED Triggerfish | All patients included in the device group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | Standard Deviation | mVEq (Sensismed Triggerfish output unit) | 24 hours |
|
|
From inform consent signature to 30 days after last exposure to device
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SENSIMED Triggerfish | All patients included in the device group |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild blurred vision | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anjali Parekh | Hamilton Glaucoma center | +1858 822-1553 | anjalism@gmail.com |
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| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tolerability of CLS | Subjective comfort level using a number between 0-10 with values ranging from 0 (no discomfort) to 10 (very severe discomfort) | Mean | Standard Deviation | units on a scale |
|
|
| 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 | Posted | Mean | Standard Deviation | mvEq | 24 hours |
|
|
|
| Other Pre-specified | Adverse Events and Serious Adverse Events | Safety will be evaluated throughout the duration of the study by collecting all adverse events | Posted | Number | Number of AE | 4 days |
|
|
|
| 0 |
| 10 |
| 10 |
| 10 |
| Mild hyperemia and palpebral conjunctiva | Eye disorders | Systematic Assessment |
|
| Superficial Punctate keratitis | Eye disorders | Systematic Assessment |
|
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| D009916 |
| Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |