Clinical trial NCT01691183: Reliability of Hertel Exophthalmometer Measurements
Official title: Reliability of Hertel Exophthalmometer Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Standardization of Hertel Measurements
Keywords: Hertel
exophthalmometer
proptosis
eye disease
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 150 consecutive adult patients of both sexes and all ages will be recruited by David Chesnutt MD from the UNC Eye Clinic. Patients taken from a pool of patients already scheduled for appointments.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Proptosis
timeFrame: approximately 5 minutes
measure: "Base Measurement"
timeFrame: approximately 5 minutes
Secondary outcomes:
measure: Orbital Disease status
timeFrame: baseline
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Kittner Eye Center
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: David Chesnutt, MD
role: PRINCIPAL_INVESTIGATOR
References: