Pascal Pascal Dynamic Contour Tonometer (DCT) Intraocular Pressure and Ocular Pulse Amplitude in Patients With Thyroid Related Orbitopathy: A Comparison to Goldmann Tonometer and to Muscles Characteristics on CT Scan
Primary Purpose
Thyroid Related Orbitopathy
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
To measure the IOP (with Goldmann and Pascal DCT tonometers) and OPA (with Pascal DCT) in primary and upright gazes
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Related Orbitopathy focused on measuring TRO
Eligibility Criteria
Inclusion Criteria:
- age > 18 yr
- agree to participate in the study and willing to sign an informed consent
Exclusion Criteria:
- other ocular diseases (besides cataract and mild hypertensive retinopathy)
- previous history of eye surgery besides cataract extraction and Nd:YAG laser capsulotomy
- moderate to severe cataract that precludes fundus examination
- pregnancy
Sites / Locations
- Goldschleger Eye Institute, Sheba Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
To measure the IOP (with Goldmann and Pascal DCT tonometers) and OPA (with Pascal DCT) in primary and upright gazes
Outcomes
Primary Outcome Measures
IOP in primary and upright gazes measured by Goldmann and Pascal Dynamic Contour tonometers.
Secondary Outcome Measures
The change in IOP & OPA as measured by Pascal Dynamic Contour Tonometer following an upright gaze
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00646295
Brief Title
Pascal Pascal Dynamic Contour Tonometer (DCT) Intraocular Pressure and Ocular Pulse Amplitude in Patients With Thyroid Related Orbitopathy: A Comparison to Goldmann Tonometer and to Muscles Characteristics on CT Scan
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Related Orbitopathy
Keywords
TRO
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
To measure the IOP (with Goldmann and Pascal DCT tonometers) and OPA (with Pascal DCT) in primary and upright gazes
Intervention Type
Device
Intervention Name(s)
To measure the IOP (with Goldmann and Pascal DCT tonometers) and OPA (with Pascal DCT) in primary and upright gazes
Other Intervention Name(s)
Pascal Dynamic Contour Tonometer, Pascal DCT, Goldmann tonometer
Intervention Description
Pascal Dynamic Contour Tonometer Goldmann Applanation Tonometer
Primary Outcome Measure Information:
Title
IOP in primary and upright gazes measured by Goldmann and Pascal Dynamic Contour tonometers.
Time Frame
one visit
Secondary Outcome Measure Information:
Title
The change in IOP & OPA as measured by Pascal Dynamic Contour Tonometer following an upright gaze
Time Frame
one time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 18 yr
agree to participate in the study and willing to sign an informed consent
Exclusion Criteria:
other ocular diseases (besides cataract and mild hypertensive retinopathy)
previous history of eye surgery besides cataract extraction and Nd:YAG laser capsulotomy
moderate to severe cataract that precludes fundus examination
pregnancy
Facility Information:
Facility Name
Goldschleger Eye Institute, Sheba Medical Center
City
Tel-Hashomer, Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ehud Rechtman, MD
Phone
972-52-2528871
Email
ehudrechtman@gmail.com
First Name & Middle Initial & Last Name & Degree
Ehud Rechtman, MD
First Name & Middle Initial & Last Name & Degree
Guy Ben-Simon, MD
12. IPD Sharing Statement
Learn more about this trial
Pascal Pascal Dynamic Contour Tonometer (DCT) Intraocular Pressure and Ocular Pulse Amplitude in Patients With Thyroid Related Orbitopathy: A Comparison to Goldmann Tonometer and to Muscles Characteristics on CT Scan
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