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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00646295
First received: March 25, 2008
Last updated: June 18, 2008
Last verified: June 2008
History of Changes
  Purpose

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).


Condition Intervention
Thyroid Related Orbitopathy
 Device: To measure the IOP (with Goldmann and Pascal DCT tonometers) and OPA (with Pascal DCT) in primary and upright gazes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

Drug Information available for: Thyroid
U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • IOP in primary and upright gazes measured by Goldmann and Pascal Dynamic Contour tonometers. [ Time Frame: one visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: June 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
To measure the IOP (with Goldmann and Pascal DCT tonometers) and OPA (with Pascal DCT) in primary and upright gazes
 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:
  • Pascal Dynamic Contour Tonometer
  • Pascal DCT
  • Goldmann tonometer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00646295

Locations
Israel
Goldschleger Eye Institute, Sheba Medical Center Recruiting
Tel-Hashomer, Ramat-Gan, Israel, 52621
Contact: Ehud Rechtman, MD     972-52-2528871     ehudrechtman@gmail.com    
Principal Investigator: Ehud Rechtman, MD            
Principal Investigator: Guy Ben-Simon, MD            
Sponsors and Collaborators
Sheba Medical Center
  More Information

No publications provided

Responsible Party: Ehud Rechtman,/MD & Guy Ben Simon/MD, Goldschleger Eye Institute, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00646295     History of Changes
Other Study ID Numbers: SHEBA-08-5058-ER-CTIL
Study First Received: March 25, 2008
Last Updated: June 18, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
TRO

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013