Systematic evaluation of wavefront-guided outcomes
Accepted 26 January 2005.
Purpose
To present a format for reporting outcomes of aberrometer-guided refractive procedures.
Setting
SurgiVision Consultants, Inc., Scottsdale, Arizona, and Food and Drug Administration, Center for Devices and Radiological Health, Rockland, Maryland, USA.
Methods
Reports of standard refractive and visual outcomes (uncorrected visual acuity, manifest refractive spherical equivalent, best spectacle-corrected visual acuity) should be provided for any refractive surgery report. Comparison of postoperative uncorrected visual acuity to preoperative best spectacle-corrected visual acuity should be included. Aberration reports should convert 2nd-order terms to refractions (measured in diopters) and use standard refractive reporting methods. Changes in coma, spherical aberration, and root-mean-square changes should be described using statistical methods for aggregate data. Underlying statistics should be reported.
Results
Aberration changes are well described by the mean error of the attempted versus achieved outcomes, comparison of the mean changes, and stability over time. Ancillary plots include histogram representation of the postoperative scores. Additional reports of visual function should be included, as appropriate.
Conclusion
Use of standardized tables and graphs permits qualitative and quantitative comparison of outcomes of refractive treatment with wavefront-guided lasers. Modifications of the recommended formats can be expected over time.
From SurgiVision Consultants, Inc. (Kezirian), Scottsdale, Arizona, and the U.S. Food and Drug Administration, Center for Devices and Radiologic Health (Drum), and Department of Health and Human Services, Food and Drug Administration, Rockville, Maryland, USA
Reprint requests to Guy M. Kezirian, MD, 28071 North 90th Way, Scottsdale, Arizona 85262, USA.
Presented at the 5th International Congress of Wavefront Sensing and Optimized Refractive Corrections, Whistler, British Columbia, Canada, February 2004.
No author has a financial or proprietary interest in any material or method mentioned.
The following individuals contributed in the preparation of this manuscript: David A. Atchison, PhD, FAAO (School of Optometry, Queensland University of Technology, Queensland, Australia); Michael Mrochen, PhD (Institute for Biomedical Engineering, University of Zurich and Swiss Federal Institute of Technology, Zurich, Switzerland).
The comments presented here represent the professional opinions of the authors and do not constitute an official document, guidance or policy of the U.S. Government, the Department of Health and Human Services, or the Food and Drug Administration, nor should any official endorsement be inferred.
ABSTRACT