Comparison of Three Corneal Horizontal Marking Techniques Using iTrace™
Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT01972191
Collaborator
(none)
156
1
10
15.6
Study Details
Study Description
Brief Summary
Before astigmatism reducing surgery, accurate corneal horizontal marking before surgery is important. Due to new corneal topographic method, iTrace™ surgical workstation, precise evaluation of corneal horizontal marking is available. In this study the investigators compared three known corneal horizontal making techniques and evaluate accuracy of each methods using iTrace™.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
156 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Study Start Date
:
Oct 1, 2012
Actual Primary Completion Date
:
Aug 1, 2013
Actual Study Completion Date
:
Aug 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group 1 Group 1 : Bare eye marking group |
|
| Group 2 Group 2 : Pendulum attached marker group |
|
| Group 3 Group 3 : Horizontal slit beam assisted marker group |
Outcome Measures
Primary Outcome Measures
- The vertical height deviation and rotational axis misalignment amount of each three marking techniques, evaluated by iTrace surgical workstation. [Within 10 minutes after corneal horizontal marking.]
Nasal and temporal marked spots saved in iTrace surgical workstation program.
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 86 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Patients who were scheduled to have cataract surgery
-
Age between 50 to 85 years
Exclusion Criteria:
- With an underlying corneal or conjunctival disorder
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine | Seoul | Korea, Republic of | 102-752 |
Sponsors and Collaborators
- Yonsei University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Cha D, Kang SY, Kim SH, Song JS, Kim HM. New axis-marking method for a toric intraocular lens: mapping method. J Refract Surg. 2011 May;27(5):375-9. doi: 10.3928/1081597X-20101005-01. Epub 2010 Oct 15.
- Hoffer KJ. Biometry of 7,500 cataractous eyes. Am J Ophthalmol. 1980 Sep;90(3):360-8.
Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01972191
Other Study ID Numbers:
- 1-2013-0049
First Posted:
Oct 30, 2013
Last Update Posted:
Oct 30, 2013
Last Verified:
Oct 1, 2013
Keywords provided by Yonsei University