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Completed

NCT Number: NCT01691183

Reliability of Hertel Exophthalmometer Measurements

The purpose of this research study is to learn about the variability in proptosis measurements. Measurements will be recorded using the Hertel exophthalmometer. This noninvasive tool is an instrument designed to measure the forward protrusion of the eye and may be used normally during a general eye exam. This instrument provides a method of evaluating and recording the progression and regression of the prominence of an eye caused by disorders such as thyroid disease and tumors of the orbit.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UNC Kittner Eye Center

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Proptosis

    Time frame: approximately 5 minutes

    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".

  2. "Base Measurement"

    Time frame: approximately 5 minutes

    User #1 will take a baseline measurement and then a second measurement to help evaluate intrauser variability. User #2 will then independently take a baseline measurement (to help evaluate interuser variability) and then a second measurement after being provided only the base measurement of user #1's first measurement, in order to help determine if standardizing the base measurement will improve interuser variability.

Secondary outcomes

  1. Orbital Disease status

    Time frame: baseline

    Record presence or absence of orbital disease at time of measurement

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 24, 2012
Registry last updated
Sep 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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