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

March 25, 2008
June 18, 2008
June 2008
June 2010   (final data collection date for primary outcome measure)
IOP in primary and upright gazes measured by Goldmann and Pascal Dynamic Contour tonometers. [ Time Frame: one visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00646295 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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
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).

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Thyroid Related Orbitopathy
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
September 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
Israel
 
NCT00646295
SHEBA-08-5058-ER-CTIL
No
Ehud Rechtman,/MD & Guy Ben Simon/MD, Goldschleger Eye Institute, Sheba Medical Center
Sheba Medical Center
Not Provided
Not Provided
Sheba Medical Center
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP