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CompletedNCT02627170Updated May 19, 2016

Measurements of Corneal Biomechanical Properties Using a Dynamic Scheimpflug Analyzer for Normal Adults in South Korea

An observational study in Healthy, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-19.

Sponsored by Yonsei University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
250
Ages
20 Years to 40 Years
Sex
All
01

Study 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 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 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 South Korea.

02

Conditions studied

  • Healthy

Keywords

  • Adults
03

In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Normal healthy population

Inclusion criteria

  • Only the participants age > 20 years old were included
  • have myopia with a spherical equivalent (SE) between 0.00 and -11.00 diopters (D)

Exclusion criteria

Exclusion Criteria:

  • Participants were excluded from analyses if they had abnormal eye-related findings except for clinically insignificant senile cataract, previous ocular or intraocular surgery, glaucoma, history of ocular diseases such as glaucoma or age-related macular degeneration, presence of corneal abnormalities such as keratoconus and forme fruste keratoconus, or corneal scarring that would preclude accurate measurements.
  • Participants with diabetes mellitus were also excluded, because of the possible effects of the disease on corneal hysteresis.None of the participants were using eye drops, especially anti-IOP agents, which can change the biomechanical properties of the cornea
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
250 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy adults group

    Age 20 to 40 years of age and have myopia with a spherical equivalent (SE) between 0.00 and -11.00 diopters (D)

    Device: dynamic Scheimpflug analyzer (corneal visualization Scheimpflug technology [Corvis ST], OCULUS, Wetzlar, Germany)

Interventions

  • Devicedynamic Scheimpflug analyzer (corneal visualization Scheimpflug technology [Corvis ST], OCULUS, Wetzlar, Germany)
06

What researchers measure

Primary outcomes

  1. applanation time (AT)

    Time frame: 1 hour

  2. applanation length (AL)

    Time frame: 1 hour

  3. corneal velocity (CV)

    Time frame: 1 hour

  4. deformation amplitude

    Time frame: 1 hour

  5. peak distance

    Time frame: 1 hour

  6. radius

    Time frame: 1 hour

  7. maximal concave power

    Time frame: 1 hour

  8. central corneal thickness (CCT)

    Time frame: 1 hour

  9. intraocular pressure (IOP)

    Time frame: 1 hour

07

Study locations

1 site
  • Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
    Seoul, 102-752, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided — undecided yet

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02627170
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Dec 10, 2015
Start date
Dec 2015
Primary completion
Mar 2016
Completion
Mar 2016
Last update
May 19, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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