Pascal Pascal Dynamic Contour Tonometer (DCT) Intraocular... | NCT00646295

Studies
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

NCT00646295

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Jun 19, 2008Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Thyroid Related Orbitopathy

Interventions

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

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jun 2010Estimated

Completion Date

Sep 2010Estimated

First Submitted Date

Mar 25, 2008

First Submission Date that Met QC Criteria

Mar 27, 2008

First Posted Date

Mar 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2008

Last Update Posted Date

Jun 19, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Sheba Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
To measure the IOP (with Goldmann and Pascal DCT tonometers) and OPA (with Pascal DCT) in primary and upright gazes	Device	Pascal Dynamic Contour Tonometer Goldmann Applanation Tonometer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IOP in primary and upright gazes measured by Goldmann and Pascal Dynamic Contour tonometers.		one visit

Secondary Outcomes

Measure	Description	Time Frame
The change in IOP & OPA as measured by Pascal Dynamic Contour Tonometer following an upright gaze		one time

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Goldschleger Eye Institute, Sheba Medical Center	Recruiting	Tel-Hashomer, Ramat-Gan		52621	Israel

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.