Eye Cyclorotation DegreeNCT00943163
Evaluation of Position-induced Cyclorotation Between Wavefront Measurement and Refractive Surgery by the Iris Registration Method
An observational study of Eye Cyclorotation Degree and Pupil Shift, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Eye Cyclorotation Degree, Pupil Shift
- How many people
- 93 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2008to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- patients undergoing bilateral wavefront-guided laser refractive surgery
Who cannot join
- patients with strabismus, extraocular muscle palsy, muscle restriction or other diseases interfering normal ocular movement.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Ophthalmology, National Taiwan University Hospital
Taipei
About this study
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.
Read the 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.
- Conditions
- Eye Cyclorotation Degree, Pupil Shift
- Keywords
- cyclorotation, pupil, laser refractive surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye Cyclorotation DegreeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yu-Chih Hou, MD, Study director, Telephone: 886-2-23123456 Ext. 65025 Email: ychou51@ntu.edu.tw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943163
- Sponsor's protocol ID
- 200906095R
- Status last verified
- Jul 2009
- First submitted
- 21 Jul 2009
- Last updated
- 22 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Position-induced Cyclorotation Between Wavefront Measurement and Refractive Surgery by the Iris Registration Method
- ClinicalTrials.gov ID
- NCT00943163
- Acronym / sponsor ID
- 200906095R
- Conditions
- Eye Cyclorotation Degree, Pupil Shift
- Keywords
- cyclorotation, pupil, laser refractive surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients undergoing bilateral wavefront-guided laser refractive surgery
Key exclusion criteria (1 listed)
- patients with strabismus, extraocular muscle palsy, muscle restriction or other diseases interfering normal ocular movement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Chih Hou, MD study director
Telephone: 886-2-23123456 Ext. 65025 Email: ychou51@ntu.edu.tw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Cyclorotation Degree and Pupil Shift, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2009.