- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00943163
Evaluation of Position-induced Cyclorotation Between Wavefront Measurement and Refractive Surgery by the Iris Registration Method
July 21, 2009 updated by: National Taiwan University Hospital
Cyclorotation of eyes may be affected by motion and orientation of the head and body.
An automated alignment method with the technique of iris recognition was used to assess the amount and orientation of position-induced cyclorotation between preoperative wavefront measurement and laser refractive surgery.
Study Overview
Status
Completed
Conditions
Detailed Description
Ninety-three consecutive patients undergoing bilateral wavefront-guided laser refractive surgery in the Department of Ophthalmology of the National Taiwan University Hospital between September 2004 and December 2007 were enrolled in this retrospective study.
Before laser refractive surgery, all patients were seated in front of the Zyoptix 100 system platform (Bausch & Lomb, salt lake city, UT, USA) and received Zywave aberrometer measurement on both eyes.
When patients were in the supine position for refractive surgery, an infrared camera mounted on the laser system (Technolas 217z100 excimer laser system, Bausch & Lomb)obtained iris images on undilated pupils before laser ablation.
Overall cyclorotation was detected by a comparison between iris images of undilated pupils in the supine position and dilated pupils in the seated position before laser treatment.
The degree and direction of position-induced cyclorotation were assessed.
Study Type
Observational
Enrollment (Actual)
93
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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Taipei, Taiwan
- Department of Ophthalmology, National Taiwan University 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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Ninety-three consecutive patients undergoing bilateral wavefront-guided laser refractive surgery in the Department of Ophthalmology of the National Taiwan University Hospital between September 2004 and December 2007.
Description
Inclusion Criteria:
- patients undergoing bilateral wavefront-guided laser refractive surgery
Exclusion Criteria:
- patients with strabismus, extraocular muscle palsy, muscle restriction or other diseases interfering normal ocular movement.
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Yu-Chih Hou, MD, Telephone: 886-2-23123456 Ext. 65025 Email: ychou51@ntu.edu.tw
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
January 1, 2008
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
July 21, 2009
First Submitted That Met QC Criteria
July 21, 2009
First Posted (Estimate)
July 22, 2009
Study Record Updates
Last Update Posted (Estimate)
July 22, 2009
Last Update Submitted That Met QC Criteria
July 21, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 200906095R
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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