Thyroid Related Orbitopathy Clinical Trial
Official title:
Pascal Dynamic Contour Tonometer Intraocular Pressure and Ocular Pulse Amplitude in Patients With Thyroid Related Orbitopathy: A Comparison to Goldmann Tonometer and to Muscles Characteristics on Orbital CT Scan
Thyroid related orbitopathy (TRO) is an autoimmune disease. Clinical features include:
orbital pressure pain, ocular soft tissue swelling, muscle enlargement around the eyeball,
eyelid retraction and bulging of the eye anteriorly out of the orbit. In many cases, the
cornea may become too dry, and as a result, corneal ulcers may form, which can become
infected. In severe cases, damage to the optic nerve can occur secondary to optic nerve
compression by enlarged muscles in the orbit.
Inflammation with soft tissue swelling occurs in the 1st stage of the disease. Scar
formation can occur in the 2nd phase. The muscles under and nasal to the eyeball are most
commonly involved. In many patients, intra-ocular pressure (IOP) can increase in primary.
IOP in upgaze (when looking up) can increase.
Goldmann applanation is the standard device to measure the IOP. It measures the average IOP
(between the "systolic", when the heart contracts, to the diastolic IOP, when the heart
relaxes). Pascal Dynamic Contour Tonometer is a new device that can measure IOP and ocular
pulse amplitude (OPA) which is the difference between diastolic IOP and systolic IOP. The
choroid is a vascular layer inside the eyeball that feeds part of the retina (the retina is
like the film in a non-digital camera). OPA is suggestive of choroidal blood flow. IOP
measurements using Pascal Dynamic Contour Tonometer are less influenced by corneal thickness
as opposed to Goldmann applanation which measures higher values in thicker corneas. In the
current study we are interested in measuring the relationships between measurements taken
with Goldmann applanation (IOP) and those taken with the Pascal Dynamic Contour Tonometer
(IOP and OPA). In addition, we will investigate the effect of orbital muscle enlargement on
IOP/OPA following an up gaze position (looking up).
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | September 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. age > 18 yr 2. agree to participate in the study and willing to sign an informed consent Exclusion Criteria: 1. other ocular diseases (besides cataract and mild hypertensive retinopathy) 2. previous history of eye surgery besides cataract extraction and Nd:YAG laser capsulotomy 3. moderate to severe cataract that precludes fundus examination 4. pregnancy |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Israel | Goldschleger Eye Institute, Sheba Medical Center | Tel-Hashomer, Ramat-Gan |
| Lead Sponsor | Collaborator |
|---|---|
| Sheba Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | IOP in primary and upright gazes measured by Goldmann and Pascal Dynamic Contour tonometers. | one visit | No | |
| Secondary | The change in IOP & OPA as measured by Pascal Dynamic Contour Tonometer following an upright gaze | one time | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00424151 -
Rituximab Treatment of Graves' Dysthyroid Ophthalmopathy
|
Phase 1/Phase 2 |