- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00439114
Comparison of Ultrasonic Pachymetry With Orbscan in Corneal Haze
February 21, 2007 updated by: Baskent University
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Adana, Turkey, 01250
- Baskent University, Faculty of Medicine, Adana Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rana Altan-Yaycioglu, M.D., Baskent University, Faculty of Medicine, Department of Ophthalmology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1016/s0886-3350(01)01162-2.
- 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. doi: 10.1016/s0886-3350(01)00820-3.
- Altan-Yaycioglu R, Pelit A, Akova YA. Comparison of ultrasonic pachymetry with Orbscan in corneal haze. Graefes Arch Clin Exp Ophthalmol. 2007 Dec;245(12):1759-63. doi: 10.1007/s00417-007-0578-5. Epub 2007 Jun 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Study Completion
June 1, 2006
Study Registration Dates
First Submitted
February 21, 2007
First Submitted That Met QC Criteria
February 21, 2007
First Posted (Estimate)
February 23, 2007
Study Record Updates
Last Update Posted (Estimate)
February 23, 2007
Last Update Submitted That Met QC Criteria
February 21, 2007
Last Verified
February 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA05/207
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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