MyopiaNCT02627157
Measurements of Corneal Biomechanical Properties Using a Dynamic Scheimpflug Analyzer for Young Healthy Adults in South Korea
An observational study of Myopia, run by Yonsei University at 1 site in South Korea.
Trial summary
The human cornea is affected by the magnitude and velocity of both internal and external forces because the cornea has both static and dynamic resistance components. Considering these natures of the human cornea, many investigators have tried to demonstrate corneal biomechanical properties to understand these… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Myopia
- What is being tested?
- Dynamic Scheimpflug Analyzer
- Type of treatment
- Medical device
- How many people
- 472 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Dec 2015to 1 Feb 2016
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young myopic patients
Who may be able to join
- Participants will be included in analyses if they are 20 to 40 years of age
- Participants who have myopia with a spherical equivalent (SE) between 0.00 and -11.00 diopters (D)
Who cannot join
- Participants will be excluded from analyses if they had previous ocular or intraocular surgery, a visual field defect, suspicious optic disc appearance, IOP ≥ 30 mmHg, or presence of corneal abnormalities such as keratoconus and forme fruste keratoconus, corneal scarring that would preclude accurate measurements.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
Seoul, 102-752
About this study
The human cornea is affected by the magnitude and velocity of both internal and external forces because the cornea has both static and dynamic resistance components. Considering these natures of the human cornea, many investigators have tried to demonstrate corneal biomechanical properties to understand these characteristics of the cornea. Corneal biomechanical properties are known to influence the accuracy of measurements in intraocular pressure (IOP) and are recognized as important factor to explain the susceptibility of development of glaucomatous damage. Until recently, the only instrument which enabled the in vivo measurements of the ocular biomechanical properties was ocular response analyzer (ORA, Reichert Ophthalmic Instruments, Depew, NY, USA).8 The ORA has been used to assess the biomechanical properties of the cornea according to the dynamic bidirectional applanation process. A dynamic Scheimpflug analyzer (corneal visualization Scheimpflug technology [Corvis ST], OCULUS, Wetzlar, Germany) has been introduced recently and has become a useful instrument for evaluating corneal biomechanical properties. The dynamic Scheimpflug analyzer captures the dynamic process of corneal deformation caused by an air puff using an ultra-high-speed Scheimpflug camera at a rate of up to 4,330 images per second. Until now, well-organized analysis on the normative data of the corneal biomechanical profiles measured with the dynamic Scheimpflug analyzer for young healthy adults has not been reported yet. Hence, in the present study, we aim to conduct normative data analysis for the corneal biomechanical properties with the dynamic Scheimpflug analyzer in a cohort of young healthy adults in South Korea.
- Conditions
- Myopia
- Being tested
- Dynamic Scheimpflug Analyzer
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Scheimpflug AnalyzerDevice
Measurements of Corneal Biomechanical Properties Using a Dynamic Scheimpflug Analyzer
| Study group | Role | What they receive |
|---|---|---|
| myopia patients | 20 to 40 years of age and have myopia with a spherical equivalent (SE) between 0.00 and -11.00 diopters (D) Receives: Device: Dynamic Scheimpflug Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
applanation time (AT)
Measured: 1 hour
applanation length (AL)
Measured: 1 hour
corneal velocity (CV)
Measured: 1 hour
deformation amplitude
Measured: 1 hour
peak distance
Measured: 1 hour
radius
Measured: 1 hour
maximal concave power
Measured: 1 hour
central corneal thickness (CCT)
Measured: 1 hour
intraocular pressure (IOP)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start2 Dec 2015
- Primary completion1 Feb 2016
- Study completion1 Feb 2016
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.
- More trials run by Yonsei UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627157
- Sponsor's protocol ID
- 4-2015-0944
- Status last verified
- Jan 2019
- First submitted
- 8 Dec 2015
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Undecided yet
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements of Corneal Biomechanical Properties Using a Dynamic Scheimpflug Analyzer for Young Healthy Adults in South Korea
- ClinicalTrials.gov ID
- NCT02627157
- Acronym / sponsor ID
- 4-2015-0944
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- 1 Feb 2016 (actual)
- Study completion
- 1 Feb 2016 (actual)
- First posted
- 10 Dec 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.
The human cornea is affected by the magnitude and velocity of both internal and external forces because the cornea has both static and dynamic resistance components. Considering these natures of the human cornea, many investigators have tried to demonstrate corneal biomechanical properties to understand these characteristics of the cornea. Corneal biomechanical properties are known to influence the accuracy of measurements in intraocular pressure (IOP) and are recognized as important factor to explain the susceptibility of development of glaucomatous damage. Until recently, the only instrument which enabled the in vivo measurements of the ocular biomechanical properties was ocular response analyzer (ORA, Reichert Ophthalmic Instruments, Depew, NY, USA).8 The ORA has been used to assess the biomechanical properties of the cornea according to the dynamic bidirectional applanation process. A dynamic Scheimpflug analyzer (corneal visualization Scheimpflug technology [Corvis ST], OCULUS, Wetzlar, Germany) has been introduced recently and has become a useful instrument for evaluating corneal biomechanical properties. The dynamic Scheimpflug analyzer captures the dynamic process of corneal deformation caused by an air puff using an ultra-high-speed Scheimpflug camera at a rate of up to 4,330 images per second. Until now, well-organized analysis on the normative data of the corneal biomechanical profiles measured with the dynamic Scheimpflug analyzer for young healthy adults has not been reported yet. Hence, in the present study, we aim to conduct normative data analysis for the corneal biomechanical properties with the dynamic Scheimpflug analyzer in a cohort of young healthy adults in South Korea.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| myopia patients | – | Device: Dynamic Scheimpflug Analyzer20 to 40 years of age and have myopia with a spherical equivalent (SE) between 0.00 and -11.00 diopters (D) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young myopic patients
Key inclusion criteria (2 listed)
- Participants will be included in analyses if they are 20 to 40 years of age
- Participants who have myopia with a spherical equivalent (SE) between 0.00 and -11.00 diopters (D)
Key exclusion criteria (1 listed)
- Participants will be excluded from analyses if they had previous ocular or intraocular surgery, a visual field defect, suspicious optic disc appearance, IOP ≥ 30 mmHg, or presence of corneal abnormalities such as keratoconus and forme fruste keratoconus, corneal scarring that would preclude accurate measurements.
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 |
|---|---|---|
| Dynamic Scheimpflug AnalyzerMeasurements of Corneal Biomechanical Properties Using a Dynamic Scheimpflug Analyzer | Device | myopia patients |
Primary outcome
applanation time (AT)
Time frame: 1 hour
applanation length (AL)
Time frame: 1 hour
corneal velocity (CV)
Time frame: 1 hour
deformation amplitude
Time frame: 1 hour
peak distance
Time frame: 1 hour
radius
Time frame: 1 hour
maximal concave power
Time frame: 1 hour
central corneal thickness (CCT)
Time frame: 1 hour
intraocular pressure (IOP)
Time frame: 1 hour
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 22 Jan 2019.
- Individual participant dataSharing planned: Undecided. Undecided yet
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Myopia, run by Yonsei University at 1 site in South Korea.
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 2 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 22 Jan 2019. 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 South Korea. 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?
applanation time (AT) (time frame: 1 hour). The study lists 9 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 22 Jan 2019.