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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

NCT ID: NCT00646295

Last Updated: 2008-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-09-30

Brief Summary

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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

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Conditions

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Thyroid Related Orbitopathy

Keywords

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TRO

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

To measure the IOP (with Goldmann and Pascal DCT tonometers) and OPA (with Pascal DCT) in primary and upright gazes

Group Type EXPERIMENTAL

To measure the IOP (with Goldmann and Pascal DCT tonometers) and OPA (with Pascal DCT) in primary and upright gazes

Intervention Type DEVICE

Pascal Dynamic Contour Tonometer Goldmann Applanation Tonometer

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Pascal Dynamic Contour Tonometer Pascal DCT Goldmann tonometer

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Goldschleger Eye Institute, Sheba Medical Center

Locations

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Goldschleger Eye Institute, Sheba Medical Center

Tel-Hashomer, Ramat-Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Ehud Rechtman, MD

Role: primary

Other Identifiers

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SHEBA-08-5058-ER-CTIL

Identifier Type: -

Identifier Source: org_study_id