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.
Standardization of Hertel Measurements
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Reliability of Hertel Exophthalmometer Measurements|
- Proptosis [ Time Frame: approximately 5 minutes ] [ Designated as safety issue: No ]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".
- "Base Measurement" [ Time Frame: approximately 5 minutes ] [ Designated as safety issue: No ]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.
- Orbital Disease status [ Time Frame: baseline ] [ Designated as safety issue: No ]Record presence or absence of orbital disease at time of measurement
|Study Start Date:||May 2012|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Subjects with or without orbital disease that present to clinic for scheduled appointments.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691183
|United States, North Carolina|
|UNC Kittner Eye Center|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||David Chesnutt, MD||UNC Chapel Hill|