Standardization of Hertel MeasurementsNCT01691183
Reliability of Hertel Exophthalmometer Measurements
An observational study of Standardization of Hertel Measurements, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Standardization of Hertel Measurements
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients will be at least 18 years old and will be able to converse in written and spoken English.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Kittner Eye Center
Chapel Hill, North Carolina, 27599
About this study
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.
Read the 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.
- Conditions
- Standardization of Hertel Measurements
- Keywords
- Hertel, exophthalmometer, proptosis, eye disease
- Medical subject headings
- Exophthalmos, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Subjects | Subjects with or without orbital disease that present to clinic for scheduled appointments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proptosis
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".
Measured: approximately 5 minutes
"Base Measurement"
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.
Measured: approximately 5 minutes
Secondary outcomes (1)
Orbital Disease status
Record presence or absence of orbital disease at time of measurement
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Standardization of Hertel MeasurementsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Chesnutt, MD, University of North Carolina, Chapel Hill
- Investigators
- David Chesnutt, MD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691183
- Sponsor's protocol ID
- 12-0705
- Status last verified
- Sep 2012
- First submitted
- 5 Jun 2012
- Last updated
- 24 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Hertel Exophthalmometer Measurements
- ClinicalTrials.gov ID
- NCT01691183
- Acronym / sponsor ID
- 12-0705
- Conditions
- Standardization of Hertel Measurements
- Keywords
- Hertel, exophthalmometer, proptosis, eye disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Subjects | – | –Subjects with or without orbital disease that present to clinic for scheduled appointments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients will be at least 18 years old and will be able to converse in written and spoken English.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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".
"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.
1 secondary outcome
Orbital Disease status
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Chesnutt, MD principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Standardization of Hertel Measurements, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proptosis (time frame: approximately 5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.