Aberration-Free Refraction Correction
Recruitment status was: Recruiting
|First Received Date ICMJE||September 12, 2005|
|Last Updated Date||September 12, 2005|
|Start Date ICMJE||June 2005|
|Primary Completion Date||Not Provided|
|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|
|Brief Title ICMJE||Aberration-Free Refraction Correction|
|Official Title ICMJE||National Taiwan University Hospital|
|Brief Summary||In the interest of improving visual quality after LASIK we have designed a multifaceted study to test the theoretical, physical, biomechanical and functional effects of commercial and independently designed aspherical ablation profiles.|
The quality of an image on the retina is determined by the optical system of the eyeball, which is dominated by the refractive contribution of the optically powerful cornea. The large difference in refractive index between air and the cornea is the basis for anterior corneal refractive surgery such as Laser in situ Keratomileusis (LASIK) which reshapes the naturally aspherical cornea to correct a patient’s vision. In addition to correcting refractive errors, current spherical LASIK treatments have been shown to increase ocular wavefront aberrations which can reduce visual quality postoperatively. Modifications of the corneal-ablation algorithm have been suggested to correct this issue.
Until recently, most ablation algorithms have relied on the Munnerlyn formula, which assumes the anterior corneal surface to be spherical before and after refractive surgery. One concept for customized ablation is to apply an ablation during the surgical procedure which has been adapted to the patient’s own aberration pattern. Since custom ablation algorithms are proprietary and we do not know how they consider the role of asphericity.
Precisely altering the corneal asphericity after refraction surgery is a complex phenomenon which includes biomechanical effects. Thus, knowledge of the cornea’s response to the different aspherical ablation profiles is vital for understanding corneal properties and prediction of surgical outcomes.
This study will involve computer simulation of ablation profiles for the respective lasers, interferometric analysis of actual ablation profiles on PMMA plates, optimization for visual correction, functional studies of the short and long term effects of the profiles on in vivo human corneas, and quantitative subjective (questionnaire and visual tests) and objective analysis (calculation of retinal image quality metrics) and comparison of the effects aspherical ablation profiles on visual quality. The completion of the project will lead to objective evaluation of current ablation profiles as well as the development and evaluation of new optimized laser refractive surgery procedures with improved outcomes.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Retrospective/Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||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 Status ICMJE||Unknown status|
|Estimated Completion Date||July 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Eyes will also be divided into groups by refractive error: Low myopia 0-3D, moderate myopia 3-6D, and high myopia 6-9 D and very high myopia > 9D MSRE. The size of the Optical Zone and Transitional Zone is measured, and results are compared for patients of similar refractive error (+/- 0.5 S +/- 0.5 C). Analysis is carried out using a matrix analysis of the total refractive error, comparison of Visual Acuity, Contrast Sensitivity and Responses on a Questionnaire to assess the patient’s quality of vision.
Equal numbers of eyes from each of the four refractive error groups and from each of the three treatment groups (OATZ profile 5, OATZ profile 6, conventional) will be measured.
We will consider patients operated on by the same doctor (Dr. Lin). We will also compare treatments of patients and wavefront maps of patients who have similar spherical and cylindrical refractive errors.
Table 1. Examination Schedule (Definitions) Visit Time Preoperative Within 30 days of surgery Operative Day Day of surgery
1 Month postop 3-5 weeks following surgery 3 Months postop 10-14 weeks following surgery
Possible additional exclusion criteria include no previous refractive surgery, no hyperopia, preop BSCVA 20/25 or better, ages from 21-60 years old, astigmatism above 2D, difficult cases and equal numbers of men and women
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Taiwan|
|Removed Location Countries|
|NCT Number ICMJE||NCT00172913|
|Other Study ID Numbers ICMJE||9461700324|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Taiwan University Hospital|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Taiwan University Hospital|
|Verification Date||June 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP