A Comprehensive Assessment of Anterior Corneal Power by Different Devices

Completed

• Conditions: Myopia
• Interventions: Device: Corneal power measurement

• Registration Number: NCT01587287
• Lead Sponsor: Wenzhou Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-04
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-04-25
• Last Update Submitted: 2012-04-28
• Study First Posted: 2012-04-30
• Last Update Posted: 2012-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Corneal power measurement	Corneal power measurement	All recruited volunteers in present study, that underwent corneal power measurement with 8 different instruments

Primary Outcome Measures

Name	Time	Method
Flat corneal power	2 weeks	The intrasession repeatability and intersession reproducibility of flat corneal curvature measurements by using the 8 commercially available instruments.
Steep corneal power	2 weeks	The intrasession repeatability and intersession reproducibility of Steep corneal curvature measurements by using the 8 commercially available instruments.

Secondary Outcome Measures

Name	Time	Method
Vector power J0	2 weeks	The intrasession repeatability and intersession reproducibility of vector power J0 measurements by using the 8 commercially available instruments.
Vector power J45	2 weeks	The intrasession repeatability and intersession reproducibility of vector power J45 measurements by using the 8 commercially available instruments.

Trial Locations

Locations (1)

Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China