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
Recruitment status was Recruiting
| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 25, 2008 |
| Last Updated Date | June 18, 2008 |
| Start Date ICMJE | June 2008 |
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
IOP in primary and upright gazes measured by Goldmann and Pascal Dynamic Contour tonometers. [ Time Frame: one visit ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00646295 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
The change in IOP & OPA as measured by Pascal Dynamic Contour Tonometer following an upright gaze [ Time Frame: one time ] [ Designated as safety issue: No ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | 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 ICMJE | 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 |
| 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). |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Condition ICMJE | Thyroid Related Orbitopathy |
| Intervention ICMJE | Device: To measure the IOP (with Goldmann and Pascal DCT tonometers) and OPA (with Pascal DCT) in primary and upright gazes
Pascal Dynamic Contour Tonometer Goldmann Applanation Tonometer
Other Names:
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| Study Arm (s) | Experimental: A
To measure the IOP (with Goldmann and Pascal DCT tonometers) and OPA (with Pascal DCT) in primary and upright gazes
Intervention: Device: To measure the IOP (with Goldmann and Pascal DCT tonometers) and OPA (with Pascal DCT) in primary and upright gazes |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Recruiting |
| Estimated Enrollment ICMJE | 30 |
| Estimated Completion Date | September 2010 |
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Not Provided |
| Location Countries ICMJE | Israel |
| Administrative Information | |
| NCT Number ICMJE | NCT00646295 |
| Other Study ID Numbers ICMJE | SHEBA-08-5058-ER-CTIL |
| Has Data Monitoring Committee | No |
| Responsible Party | Ehud Rechtman,/MD & Guy Ben Simon/MD, Goldschleger Eye Institute, Sheba Medical Center |
| Study Sponsor ICMJE | Sheba Medical Center |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Sheba Medical Center |
| Verification Date | June 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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