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Reliability of Hertel Exophthalmometer Measurements


N/A
18 Years
N/A
Not Enrolling
Both
Standardization of Hertel Measurements

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Trial Information

Reliability of Hertel Exophthalmometer Measurements


Aim 1. In order to determine intrauser reliability of the Hertel exophthalmometer, patients
will have 2 independent exams using the Hertel exophthalmometer on the same day performed by
each of the same researcher (either DAC or HLP) in a blinded fashion. For each patient, we
will independently measure the base value and the values for the right and left eye
proptosis, respectively, using the same Hertel exophthalmometer. A randomization process
will be employed to determine which researcher (either DAC or HLP) will take the first set
of measurements. The distance of the observer from the patient will be standardized for all
measurements. Patient research data will be de-identified and recorded for each patient and
subsequently analyzed for interobserver reliability.

Aim 2. In order to determine interuser reliability of the Hertel exophthalmometer, patients
will have a second independent exam on the same day by the second observer as determined for
Aim 1 above. For each patient, we will independently measure the base value and the values
for the right and left eye proptosis, respectively, using the same Hertel exophthalmometer.
The distance of the observer from the patient will be standardized for all measurements.

Patient research data will be de-identified and recorded for each patient and subsequently
analyzed for interobserver reliability.

Aim 3. Variability in Hertel measurements may be related in large part to differences in the
base measurement. The base measurement is determined by the bony orbital structures and
should not be significantly affected over time by the soft tissue remodeling commonly seen
in TED and most other orbital disease processes. We will have the second observer re-measure
the same patient using the same Hertel exophthalmometer by beginning with the same base
measurement determined by the first observer. Again, all measurement distances will be
standardized. No other information will be provided to the second observer other than the
beginning base measurement. Patient research data will again be de-identified prior to
recording the information and subsequently analyzed to determine if beginning with the same
base improves interobserver reliability.


Inclusion Criteria:



- Patients will be at least 18 years old and will be able to converse in written and
spoken English.

Exclusion Criteria:

- None

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Proptosis

Outcome Description:

Amount of protrusion of eye from orbital rim measured in millimeters. Two people will be taking both a baseline and a secondary measurement to assess standardization of the "base measurement".

Outcome Time Frame:

approximately 5 minutes

Safety Issue:

No

Principal Investigator

David Chesnutt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Chapel Hill

Authority:

United States: Institutional Review Board

Study ID:

12-0705

NCT ID:

NCT01691183

Start Date:

May 2012

Completion Date:

June 2012

Related Keywords:

  • Standardization of Hertel Measurements
  • Hertel
  • exophthalmometer
  • proptosis
  • eye disease

Name

Location

UNC Kittner Eye CenterChapel Hill, North Carolina  27599