Corneal Asphericity Adjustment (Q Adjustment) in Myopic and Hyperopic Patients Undergoing Refractive Correction With Excimer Laser

This study has been completed.

Sponsor:

Information provided by:

Democritus University of Thrace

ClinicalTrials.gov Identifier:

NCT01296867

First received: February 15, 2011

Last updated: NA

Last verified: February 2011

History: No changes posted

Tracking Information
First Received Date ^ICMJE	February 15, 2011
Last Updated Date	February 15, 2011
Start Date ^ICMJE	March 2006
Primary Completion Date	March 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Corneal Asphericity Adjustment (Q Adjustment) in Myopic and Hyperopic Patients Undergoing Refractive Correction With Excimer Laser
Official Title ^ICMJE	Not Provided
Brief Summary	To study the postoperative results in myopic and hyperopic eyes treated with two different laser ablation algorithms (STD and F-CAT), both FDA approved.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Forty eight myopic (24 patients) and 24 hyperopic eyes (12 patients)
Condition ^ICMJE	Myopia Hyperopia
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	36
Completion Date	May 2009
Primary Completion Date	March 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Myopic and hyperopic eyes eligible for LASIK or PRK refractive correction Central corneal thickness more than 500 micrometers Exclusion Criteria: Topographies of less than 55% of successful total sampled area and eyes exhibiting asphericity variations, in either the horizontal or the vertical axis, greater than 0.2 Corneal scarring Cataract surgery Corneal ulceration Topographical abnormalities
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01296867
Other Study ID Numbers ^ICMJE	Q-value
Has Data Monitoring Committee	No
Responsible Party	Eleftherios Paschalis / PhD, Eye Institute of Thrace / Democritus University
Study Sponsor ^ICMJE	Democritus University of Thrace
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Democritus University of Thrace
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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