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Evaluation of Position-induced Cyclorotation Between Wavefront Measurement and Refractive Surgery by the Iris Registration Method

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00943163
First Posted: July 22, 2009
Last Update Posted: July 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
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.

Condition
Eye Cyclorotation Degree Pupil Shift

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Position-induced Cyclorotation Between Wavefront Measurement and Refractive Surgery by the Iris Registration Method

Further study details as provided by National Taiwan University Hospital:

Enrollment: 93
Study Start Date: January 2008
Study Completion Date: October 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00943163


Locations
Taiwan
Department of Ophthalmology, National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Yu-Chih Hou, MD Telephone: 886-2-23123456 Ext. 65025 Email: ychou51@ntu.edu.tw
  More Information

ClinicalTrials.gov Identifier: NCT00943163     History of Changes
Other Study ID Numbers: 200906095R
First Submitted: July 21, 2009
First Posted: July 22, 2009
Last Update Posted: July 22, 2009
Last Verified: July 2009

Keywords provided by National Taiwan University Hospital:
cyclorotation
pupil
laser refractive surgery