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Comparison of Ultrasonic Pachymetry With Orbscan in Corneal Haze

This study has been completed.
Sponsor:
Information provided by:
Baskent University
ClinicalTrials.gov Identifier:
NCT00439114
First received: February 21, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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.


Condition
Corneal Opacity

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Comparison of Ultrasonic Pachymetry With Orbscan in Corneal Haze

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baskent University:

Estimated Enrollment: 40
Study Start Date: July 2005
Estimated Study Completion Date: June 2006
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 71 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439114

Locations
Turkey
Baskent University, Faculty of Medicine, Adana Hospital
Adana, N.a., Turkey, 01250
Sponsors and Collaborators
Baskent University
Investigators
Principal Investigator: Rana Altan-Yaycioglu, M.D. Baskent University, Faculty of Medicine, Department of Ophthalmology
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00439114     History of Changes
Other Study ID Numbers: KA05/207
Study First Received: February 21, 2007
Last Updated: February 21, 2007
Health Authority: Turkey: Ministry of Health

Keywords provided by Baskent University:
Corneal topography, corneal opacity, keratitis, trachoma

Additional relevant MeSH terms:
Corneal Opacity
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013