MyopiaNCT03658239
Corneal Biomechanics Study
A study testing Inversion in people with Myopia, run by University of Rochester.
Trial summary
The goal of the study is to investigate relationship between the corneal response to a temporary increase in intraocular pressure and corneal mechanical properties. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Inversion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Dec 2020
- Phase
- Interventional
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A person is eligible for inclusion in the study if he/she:
- Is an adult between the ages of 18 and 55.
- Is under 250 pounds.
Who cannot join
- A person will be excluded from the study if he/she:
- Is under the age of 18 or over the age of 55 yrs.
- Weighs more than 250 pounds.
- Has clinically significant dry eye.
- Has glaucoma.
- Has hypertension.
Show all 18Show fewer
- Has prior CVA.
- Has cardiovascular disease.
- Has lower extremity joint injury, damage, or replacement.
- Has baseline bradycardia.
- Has any orthopaedic injuries.
- Is pregnant.
- Has hiatal and ventral hernias.
- Has vertigo.
- Has acid reflux (GERD).
- Is undergoing myopia control treatment (e.g. atropinisation, Ortho-K, bifocal contact lenses etc.).
- Has conditions or has undergone procedures resulting in significant corneal irregularity (e.g. keratoconus, corneal transplant, etc.). This does not include astigmatism and basic refractive errors.
- Has any ocular or systemic diseases that, in the opinion of the PI/SI, would interfere with obtaining a measurement.
About this study
Official title: The Investigation of Corneal Biomechanics Through the Changes in the Intraocular Pressure
The goal of the study is to investigate relationship between the corneal response to a temporary increase in intraocular pressure and corneal mechanical properties.
Read the detailed description
The preliminary theoretical study in which the corneal geometry at different intraocular pressure (IOP) levels is investigated using a theoretical biomechanical cornea model found changes in both conventional refractive error (sphere and cylinder) and irregular astigmatism i.e. higher order aberrations (e.g. spherical aberration, trefoil and quadrafoil). This is due to the mechanical characteristics of the cornea determined largely by interaction between collagen fibrils organization and extrafibrillar matrix material properties. Corneal geometry and the material properties are the two main factors that contribute to the changes in corneal aberrations with IOP elevation. These aberration changes due to the variation of IOP and the material properties of the cornea can be measured routinely with corneal topography systems (UR) and Brillouin ocular scanner (MGH), respectively and can guide the investigators to study their impact on optical and biomechanical behaviors of the cornea.
- Conditions
- Myopia
- Being tested
- Inversion
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InversionOther
Inversions will be done while the subject is on the inversion table. The subject will be inverted to 135, 150 and 165 degrees. There inversion will not last longer than 3 minutes at a time. The inversion will be terminated if the subject's blood pressure drops below 50 mmHg diastolic or if the subject's blood pressure increases more than 50 mmHg systolic.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Subjects will undergo 4-5 visits total over the course of 6 months. There will be 3-4 visits that will be done at the Flaum Eye Institute. During these sessions the subject will be measured with a stationary topographer (GALILEI G4), with a rotatable topography measurement (Oculus Topographer) and a Tonometer. The subject's heart rate and blood pressure will also be measured (using a commercially available blood pressure and heart rate meter).
The GALILEI measurement will only be done once. The rest of the measurements will be done up to 4 times. Once at the start of the study session then, after the subject has been inverted using a commercially available inversion table to first 135 degrees, then 150 degrees and finally to 165 degrees.
The blood pressure and heart rate will be monitored to ensure subject safety.
There will also be one visit at the Massachusetts General Hospital. The visit will be 2 hours and will involve a Brillouin Microscopy measurement. Receives: Other: Inversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Surface Topography Measurement
Corneal Surface Topography measurement will be collected at each of the 3-4 study visits at the Flaum Eye Institute. The numerical data generated will be analyzed and compared within each subject as well as across subjects.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study startDec 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Organizational Issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geunyoung Yoon, University of Rochester
- Investigators
- Geunyoung Yoon, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658239
- Sponsor's protocol ID
- 71844
- Status last verified
- Jan 2020
- First submitted
- 1 Jun 2018
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Corneal Biomechanics Through the Changes in the Intraocular Pressure
- ClinicalTrials.gov ID
- NCT03658239
- Acronym / sponsor ID
- 71844
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Organizational Issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 5 Sep 2018 (actual)
- 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 goal of the study is to investigate relationship between the corneal response to a temporary increase in intraocular pressure and corneal mechanical properties.
Detailed description
The preliminary theoretical study in which the corneal geometry at different intraocular pressure (IOP) levels is investigated using a theoretical biomechanical cornea model found changes in both conventional refractive error (sphere and cylinder) and irregular astigmatism i.e. higher order aberrations (e.g. spherical aberration, trefoil and quadrafoil). This is due to the mechanical characteristics of the cornea determined largely by interaction between collagen fibrils organization and extrafibrillar matrix material properties. Corneal geometry and the material properties are the two main factors that contribute to the changes in corneal aberrations with IOP elevation. These aberration changes due to the variation of IOP and the material properties of the cornea can be measured routinely with corneal topography systems (UR) and Brillouin ocular scanner (MGH), respectively and can guide the investigators to study their impact on optical and biomechanical behaviors of the cornea.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: InversionSubjects will undergo 4-5 visits total over the course of 6 months. There will be 3-4 visits that will be done at the Flaum Eye Institute. During these sessions the subject will be measured with a stationary topographer (GALILEI G4), with a rotatable topography measurement (Oculus Topographer) and a Tonometer. The subject's heart rate and blood pressure will also be measured (using a commercially available blood pressure and heart rate meter). The GALILEI measurement will only be done once. The rest of the measurements will be done up to 4 times. Once at the start of the study session then, after the subject has been inverted using a commercially available inversion table to first 135 degrees, then 150 degrees and finally to 165 degrees. The blood pressure and heart rate will be monitored to ensure subject safety. There will also be one visit at the Massachusetts General Hospital. The visit will be 2 hours and will involve a Brillouin Microscopy measurement. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is an adult between the ages of 18 and 55.
- Is under 250 pounds.
Key exclusion criteria (18 listed)
- Is under the age of 18 or over the age of 55 yrs.
- Weighs more than 250 pounds.
- Has clinically significant dry eye.
- Has glaucoma.
- Has hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InversionInversions will be done while the subject is on the inversion table. The subject will be inverted to 135, 150 and 165 degrees. There inversion will not last longer than 3 minutes at a time. The inversion will be terminated if the subject's blood pressure drops below 50 mmHg diastolic or if the subject's blood pressure increases more than 50 mmHg systolic. | Other | Experimental |
Primary outcome
Corneal Surface Topography Measurement
Time frame: 6 months
Corneal Surface Topography measurement will be collected at each of the 3-4 study visits at the Flaum Eye Institute. The numerical data generated will be analyzed and compared within each subject as well as across subjects.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- 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.
Geunyoung Yoon, PhD principal investigator
University of Rochester
Questions about this trial
What is this clinical trial studying?
A study testing Inversion in people with Myopia, run by University of Rochester.
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 3 inclusion and 18 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: withdrawn, as of the sponsor's last update on 29 Jan 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Corneal Surface Topography Measurement (time frame: 6 months). 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 29 Jan 2020; AzTrials last refreshed its copy on 29 Oct 2026.