Systematic evaluation of wavefront-guided outcomes

To present a format for reporting outcomes of aberrometer-guided refractive procedures.

SurgiVision Consultants, Inc., Scottsdale, Arizona, and Food and Drug Administration, Center for Devices and Radiological Health, Rockland, Maryland, USA.

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.

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.

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.