Comparison of Ultrasonic Pachymetry With Orbscan in Corneal Haze

Corneal Opacity Clinical Trial

Official title:

Comparison of Ultrasonic Pachymetry With Orbscan in Corneal Haze

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439114
• Other study ID #: KA05/207
• Status: Completed
• Phase: N/A
• First received: February 21, 2007
• Last updated: February 21, 2007
• Start date: July 2005
• Est. completion date: June 2006

Study information

• Verified date: February 2007
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

This study is planned to compare the results of ultrasonic and Orbscan pachymetry in corneal haze not related to surgery. Corneal haze is graded with slit-lamp by a single examiner. Ultrasonic and Orbscan II pachymetry measurements are obtained. Paired t and Kruskal-Wallis tests are used to evaluate the difference between ultrasonic and Orbscan pachymetry measurements. Correlation of the two methods and haze grade is determined with Kendall’s tau-b correlation analysis.

Description:

We planned this study to compare the results of ultrasonic and Orbscan pachymetry in corneal haze not related to surgery. In this institutional based, prospective, controlled clinical trial subjects with corneal haze not related to surgery are included. Normal eyes are used as control group to calculate the customized acoustic factor. Corneal haze is graded with slit-lamp by a single examiner. Ultrasonic and Orbscan II pachymetry measurements are obtained by one technician each masked to the other measurement. Paired t and Kruskal-Wallis tests are used to evaluate the difference between ultrasonic and Orbscan pachymetry measurements. Correlation of the two methods and haze grade is determined with Kendall’s tau-b correlation analysis. According to the results of the study, we will determine which method is accurate in subjects with corneal haze.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 71 Years

Eligibility

Inclusion Criteria:

• Patients with significant corneal haze on slit-lamp are included in the study group. 50 eyes of 50 age-matched patients with normal eye and clear cornea are included in the control group. Only one eye of each subject is included.

Exclusion Criteria:

• Exclusion criteria to participate in the study are previous ocular surgery, history of contact lens use, glaucoma, and topical ocular medication use, excluding artificial tears.

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Corneal Opacity

Locations

Country	Name	City	State
Turkey	Baskent University, Faculty of Medicine, Adana Hospital	Adana	N.a.

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Boscia F, La Tegola MG, Alessio G, Sborgia C. Accuracy of Orbscan optical pachymetry in corneas with haze. J Cataract Refract Surg. 2002 Feb;28(2):253-8. — View Citation

Iskander NG, Anderson Penno E, Peters NT, Gimbel HV, Ferensowicz M. Accuracy of Orbscan pachymetry measurements and DHG ultrasound pachymetry in primary laser in situ keratomileusis and LASIK enhancement procedures. J Cataract Refract Surg. 2001 May;27(5):681-5. — View Citation