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

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627157
• Other study ID #: 4-2015-0944
• Status: Completed
• Start date: December 2, 2015
• Est. completion date: February 1, 2016

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: February 1, 2016
• Est. primary completion date: February 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Dynamic Scheimpflug Analyzer
Measurements of Corneal Biomechanical Properties Using a Dynamic Scheimpflug Analyzer

Locations

Country	Name	City	State
Korea, Republic of	Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	applanation time (AT)		1 hour
Primary	applanation length (AL)		1 hour
Primary	corneal velocity (CV)		1 hour
Primary	deformation amplitude		1 hour
Primary	peak distance		1 hour
Primary	radius		1 hour
Primary	maximal concave power		1 hour
Primary	central corneal thickness (CCT)		1 hour
Primary	intraocular pressure (IOP)		1 hour