StrabismusNCT02454920
Measurement of Insertion of Extraocular Muscles Using Anterior Segment Optical Coherence Tomography
An observational study of Strabismus and Tomography, Optical Coherence, run by University of Miami.
Trial summary
Study designed to determine the ability and accuracy of anterior segment optical coherence tomography (AS-OCT) to measure the distance between the corneoscleral limbus and the insertion site of the extraocular muscles (EOM) in adults with and without previous strabismus surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Strabismus, Tomography, Optical Coherence
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jan 2016
- How long will I take part?
- 12 Months
- 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: All patients age greater then 18 years undergoing a strabismus evaluation at the Bascom Palmer Eye Institute
Who may be able to join
- All patients age ≥ 18 years undergoing a strabismus evaluation at the Bascom Palmer Eye Institute will be invited to participate. Members of the study team will be involved in the clinical evaluation. The physician will determine if the patient has strabismus and whether strabismus surgery is advisable.
Who cannot join
- Patient who is unwilling to participate the study.
- A clinical scenario in which AS-OCT examination is not likely to be successful (e.g. an uncooperative patient).
About this study
Official title: Measurement of the Distance Between the Limbus and Insertion of Extraocular Muscles Using Anterior Segment Optical Coherence Tomography
Study designed to determine the ability and accuracy of anterior segment optical coherence tomography (AS-OCT) to measure the distance between the corneoscleral limbus and the insertion site of the extraocular muscles (EOM) in adults with and without previous strabismus surgery. And to compare in surgical patients the pre-operative AS-OCT limbal-muscle insertion distance measurement to the intraoperative limbal-muscle insertion measurement using calipers (gold standard).
Read the detailed description
The treatment of strabismus is often surgical. A better surgical plan would be possible if the exact limbus-insertion distance of the extraocular muscles was known. The clinical ophthalmologic examination, such as slit lamp biomicroscopy, cannot elucidate the muscle insertion position prior to surgery. This information is especially important in patients who have undergone prior strabismus surgery. In these patients, previous surgical data may not be available or the muscle insertion may be in a different location than expected. Thus, a preoperative imaging study that could accurately locate the muscle insertion may be useful for designing the surgical plan, possibly improving the success of the surgery, and reducing operative time and intraoperative complications.
Previous studies that used computed tomography (CT) scans and high-resolution magnetic resonance imaging (MRI), have failed to reliably detect the rectus muscle insertions. Ocular ultrasound allows anatomic visualization of the EOM, but has a low image resolution. Ultrasound biomicroscopy (UBM), can accurately measure the limbus-insertion distance, however, it induces significant measurement errors due to the pressure applied to the globe during examination. The recent advances in AS-OCT imaging allow non-invasive, detailed, cross-sectional examination of anterior segment structures by generating a two-dimensional high resolution image from a reflected light beam. Two previous studies have successfully used AS-OCT to analyze EOM insertions, but the number of participants was small and patients with previous strabismus muscle surgery were not included.
The investigators purpose is to gather limbus-EOM insertion distance data using the AS-OCT in a greater number of patients, include patients who have undergone previous strabismus procedures, and correlate AS-OCT measurements with intraoperative findings in those patients undergoing strabismus surgery.
Procedures
- After recruitment, a written consent will be obtained from subjects who agree to participate.
- A review of medical records will be performed to obtain demographics data, type of strabismus, history of previous eye surgery, etc (see Data Collection Sheet)
- AS-OCT imaging of the rectus muscles will be performed in all patients using the Visante (Visante AS-OCT; Carl Zeiss Meditec) and/or Heidelberg Spectralis (Spectralis AS-OCT; Heidelberg Engineering) instruments.
- For patients undergoing strabismus surgery, the distance from the corneoscleral limbus to the insertion site of the rectus muscles will be measured with calipers at the time of the surgery.
- After the surgery, AS-OCT imaging of the rectus muscles will be performed during routinely scheduled post-operative clinic visits.
All acquired images will be stored in the Bascom Palmer Eye Institute MERGE HealthCare Completes Acquisition of Ophthalmic Imaging Systems (OIS), a clinical imaging storage system, which is secured against unauthorized access. All background information will be entered into REDCAP data capturing system by one of the investigators and be accessible only to the investigators (http://www.project-redcap.org/).
The AS-OCT devices that will be used are commercially available, FDA approved, and routinely used in clinical settings to evaluate the anterior and posterior segments of the eye. There are no experimental imaging procedures planned for the purpose of this study. All imaging acquisition protocols have been well-established and are non-invasive. There is no contact with the eye during image acquisition. This exposes the subjects to no greater than minimal risk as the result of participating in this study.
All eligible adult patients who are undergoing strabismus evaluation at the Bascom Palmer Eye Institute will be invited to participate. The consent processes will occur during the clinic visit. The study does not involve any additional clinic visits. The patient will have ample opportunity to discuss the study, review the consent form, and sign the consent form during the course of the visit. This study will follow the SOP: Informed Consent Process for Research (HRP-090).
Non-English Speaking Subjects We will exclude patients whose English proficiency precludes reading the form and understanding its contents.
- Conditions
- Strabismus, Tomography, Optical Coherence
- Keywords
- Strabismus, Optical Coherence Tomography, Extraocular muscles
- Medical subject headings
- Strabismus
What is being measured
The primary outcome is the main question the study is designed to answer.
Limbus to extraocular muscles insertion distance
Measurement of the limbus to insertion distance with OCT
Measured: Baseline measurement
Secondary outcomes (1)
Comparison between intra operative and OCT measurements of the distance from the limbus to extraocular muscles insertion
Measurement of the limbus to insertion distance with OCT (mm) and measurement of the limbus to insertion distance with a caliper at time of surgery (mm)
Measured: From date of baseline to date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrabismusStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilda Capo, University of Miami
- Investigators
- Hilda Capo, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454920
- Sponsor's protocol ID
- 20150332
- Status last verified
- Jun 2017
- First submitted
- 19 May 2015
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Liu X, Wang F, Xiao Y, Ye X, Hou L. Measurement of the limbus-insertion distance in adult strabismus patients with anterior segment optical coherence tomography. Invest Ophthalmol Vis Sci. 2011 Oct 28;52(11):8370-3. doi: 10.1167/iovs.11-7752.
PubMed 21948556Park KA, Lee JY, Oh SY. Reproducibility of horizontal extraocular muscle insertion distance in anterior segment optical coherence tomography and the effect of head position. J AAPOS. 2014 Feb;18(1):15-20. doi: 10.1016/j.jaapos.2013.11.005.
PubMed 24568976Dai S, Kraft SP, Smith DR, Buncic JR. Ultrasound biomicroscopy in strabismus reoperations. J AAPOS. 2006 Jun;10(3):202-5. doi: 10.1016/j.jaapos.2006.01.209.
PubMed 16814170
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Distance Between the Limbus and Insertion of Extraocular Muscles Using Anterior Segment Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT02454920
- Acronym / sponsor ID
- 20150332
- Conditions
- Strabismus, Tomography, Optical Coherence
- Keywords
- Strabismus, Optical Coherence Tomography, Extraocular muscles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 May 2015 (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.
Study designed to determine the ability and accuracy of anterior segment optical coherence tomography (AS-OCT) to measure the distance between the corneoscleral limbus and the insertion site of the extraocular muscles (EOM) in adults with and without previous strabismus surgery. And to compare in surgical patients the pre-operative AS-OCT limbal-muscle insertion distance measurement to the intraoperative limbal-muscle insertion measurement using calipers (gold standard).
Detailed description
The treatment of strabismus is often surgical. A better surgical plan would be possible if the exact limbus-insertion distance of the extraocular muscles was known. The clinical ophthalmologic examination, such as slit lamp biomicroscopy, cannot elucidate the muscle insertion position prior to surgery. This information is especially important in patients who have undergone prior strabismus surgery. In these patients, previous surgical data may not be available or the muscle insertion may be in a different location than expected. Thus, a preoperative imaging study that could accurately locate the muscle insertion may be useful for designing the surgical plan, possibly improving the success of the surgery, and reducing operative time and intraoperative complications.
Previous studies that used computed tomography (CT) scans and high-resolution magnetic resonance imaging (MRI), have failed to reliably detect the rectus muscle insertions. Ocular ultrasound allows anatomic visualization of the EOM, but has a low image resolution. Ultrasound biomicroscopy (UBM), can accurately measure the limbus-insertion distance, however, it induces significant measurement errors due to the pressure applied to the globe during examination. The recent advances in AS-OCT imaging allow non-invasive, detailed, cross-sectional examination of anterior segment structures by generating a two-dimensional high resolution image from a reflected light beam. Two previous studies have successfully used AS-OCT to analyze EOM insertions, but the number of participants was small and patients with previous strabismus muscle surgery were not included.
The investigators purpose is to gather limbus-EOM insertion distance data using the AS-OCT in a greater number of patients, include patients who have undergone previous strabismus procedures, and correlate AS-OCT measurements with intraoperative findings in those patients undergoing strabismus surgery.
Procedures
- After recruitment, a written consent will be obtained from subjects who agree to participate.
- A review of medical records will be performed to obtain demographics data, type of strabismus, history of previous eye surgery, etc (see Data Collection Sheet)
- AS-OCT imaging of the rectus muscles will be performed in all patients using the Visante (Visante AS-OCT; Carl Zeiss Meditec) and/or Heidelberg Spectralis (Spectralis AS-OCT; Heidelberg Engineering) instruments.
- For patients undergoing strabismus surgery, the distance from the corneoscleral limbus to the insertion site of the rectus muscles will be measured with calipers at the time of the surgery.
- After the surgery, AS-OCT imaging of the rectus muscles will be performed during routinely scheduled post-operative clinic visits.
All acquired images will be stored in the Bascom Palmer Eye Institute MERGE HealthCare Completes Acquisition of Ophthalmic Imaging Systems (OIS), a clinical imaging storage system, which is secured against unauthorized access. All background information will be entered into REDCAP data capturing system by one of the investigators and be accessible only to the investigators (http://www.project-redcap.org/).
The AS-OCT devices that will be used are commercially available, FDA approved, and routinely used in clinical settings to evaluate the anterior and posterior segments of the eye. There are no experimental imaging procedures planned for the purpose of this study. All imaging acquisition protocols have been well-established and are non-invasive. There is no contact with the eye during image acquisition. This exposes the subjects to no greater than minimal risk as the result of participating in this study.
All eligible adult patients who are undergoing strabismus evaluation at the Bascom Palmer Eye Institute will be invited to participate. The consent processes will occur during the clinic visit. The study does not involve any additional clinic visits. The patient will have ample opportunity to discuss the study, review the consent form, and sign the consent form during the course of the visit. This study will follow the SOP: Informed Consent Process for Research (HRP-090).
Non-English Speaking Subjects We will exclude patients whose English proficiency precludes reading the form and understanding its contents.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients age greater then 18 years undergoing a strabismus evaluation at the Bascom Palmer Eye Institute
Key inclusion criteria (1 listed)
- All patients age ≥ 18 years undergoing a strabismus evaluation at the Bascom Palmer Eye Institute will be invited to participate. Members of the study team will be involved in the clinical evaluation. The physician will determine if the patient has strabismus and whether strabismus surgery is advisable.
Key exclusion criteria (2 listed)
- Patient who is unwilling to participate the study.
- A clinical scenario in which AS-OCT examination is not likely to be successful (e.g. an uncooperative patient).
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
Limbus to extraocular muscles insertion distance
Time frame: Baseline measurement
Measurement of the limbus to insertion distance with OCT
1 secondary outcome
Comparison between intra operative and OCT measurements of the distance from the limbus to extraocular muscles insertion
Time frame: From date of baseline to date of surgery
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 2 Jul 2017.
- Background: PubMed 21948556Liu X, Wang F, Xiao Y, Ye X, Hou L. Measurement of the limbus-insertion distance in adult strabismus patients with anterior segment optical coherence tomography. Invest Ophthalmol Vis Sci. 2011 Oct 28;52(11):8370-3. doi: 10.1167/iovs.11-7752.
- Background: PubMed 24568976Park KA, Lee JY, Oh SY. Reproducibility of horizontal extraocular muscle insertion distance in anterior segment optical coherence tomography and the effect of head position. J AAPOS. 2014 Feb;18(1):15-20. doi: 10.1016/j.jaapos.2013.11.005.
- Background: PubMed 16814170Dai S, Kraft SP, Smith DR, Buncic JR. Ultrasound biomicroscopy in strabismus reoperations. J AAPOS. 2006 Jun;10(3):202-5. doi: 10.1016/j.jaapos.2006.01.209.
- Individual participant dataSharing planned: No
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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.
Hilda Capo, MD principal investigator
Professor
Questions about this trial
What is this clinical trial studying?
An observational study of Strabismus and Tomography, Optical Coherence, run by University of Miami.
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 2 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Limbus to extraocular muscles insertion distance (time frame: Baseline measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02454920, which also lists 3 linked publications.
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 2 Jul 2017.