A Comprehensive Assessment of Anterior Corneal Power by Different Devices

Myopia Clinical Trial

Official title:

A Comprehensive Assessment of the Precision and Agreement of Anterior Corneal Power Measurements Obtained Using Different Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587287
• Other study ID #: YNKT201101
• Status: Completed
• Phase: N/A
• First received: April 23, 2012
• Last updated: April 28, 2012
• Start date: April 2011
• Est. completion date: July 2011

Study information

• Verified date: January 2011
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

To comprehensively assess the precision and agreement of anterior corneal power measurements using 8 different devices.

Description:

Volunteers with healthy corneas will be measured by different instruments to detect their anterior corneal power. Only the right eye of each subject was selected. Measurements were repeated in the second session scheduled 1 to 2 weeks later.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• healthy cornea,

• best corrected distance visual acuity (BCVA) equal to or better than 20/25,

• willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

• History of refractive surgery or any keratoplasty procedure,

• use of contact lenses,

• history of corneal dystrophies or degenerative diseases,

• history of glaucoma or ocular hypertension,

• significant subjective dry eye symptoms, Schirmer I test results of less than 5.0 mm, tear film break-up time shorter than 5 seconds and corneal fluorescein staining positive.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Corneal power measurement
All subjects will be underwent a full ophthalmic examination including vision, auto- and subjective refraction, slit-lamp examination, non-contact tonometry, corneal power measurements with the 8 devices and fundus examination.

Locations

Country	Name	City	State
China	Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flat corneal power	The intrasession repeatability and intersession reproducibility of ?at corneal curvature measurements by using the 8 commercially available instruments.	2 weeks	No
Primary	Steep corneal power	The intrasession repeatability and intersession reproducibility of Steep corneal curvature measurements by using the 8 commercially available instruments.	2 weeks	No
Secondary	Vector power J0	The intrasession repeatability and intersession reproducibility of vector power J0 measurements by using the 8 commercially available instruments.	2 weeks	No
Secondary	Vector power J45	The intrasession repeatability and intersession reproducibility of vector power J45 measurements by using the 8 commercially available instruments.	2 weeks	No