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Reliability of Hertel Exophthalmometer Measurements

NCT ID: NCT01691183

Last Updated: 2012-09-24

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

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Standardization of Hertel Measurements

Keywords

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Hertel exophthalmometer proptosis eye disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Subjects

Subjects with or without orbital disease that present to clinic for scheduled appointments.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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David Chesnutt, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Chesnutt, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

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UNC Kittner Eye Center

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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12-0705

Identifier Type: -

Identifier Source: org_study_id