Comparative Of Clinical And Patient Reported Outcomes For A New Wavefront Guided Ablation Technologies

To compare outcomes of iDesign 2.0, a wavefront guided methodology, with a previously released version in a comparative population and setting.

Private Refractive Surgery (Optical Express)

Cohorts consisted of patients who underwent bilateral, LASIK procedures using one of two ablation technologies: Wavefront CustomVue or iDesign 2.0. A Stratified Random Sample of 2000 patients per cohort was extracted. Manifest refraction and monocular and binocular UCDVA were recorded 1 day, 1 week, 1 month and 3 months post operatively. Patient questionnaire included domains for satisfaction, dry eye difficulty, and visual phenomena. Complications were recorded in the electronic medical record at any point in the postoperative time window.

Pre-op refractive range included up to -11.00D of myopia with up to -5.00D of astigmatism. In early postoperative, iDesign 2.0 exhibited a mean shift in manifest sphere towards hyperopia of approximately 0.25D. By 1 month postop this shift was no longer evident, and iDesign 2.0 had statistically significant higher levels of UCDVA with 99.3% of patients reaching binocular UCDVA of 20/20 or better and 100% reaching 20/25 or better. This trend was maintained at the 3 month visit. Loss of > 2 lines in BCDVA occurred in < 1% with no statistically significant difference between cohorts. The two cohorts had high levels of patient reported satisfaction, with iDesign 2.0 reporting highest at 96.7% of patients being “very satisfied” or “satisfied”.

The two cohorts provide safe and effective wavefront guided treatment options. A difference in the iDesign 2.0 healing pattern in early post-operative phase was noted. Percent of patients reaching 20/20 was higher for iDesign 2.0 at 1 and 3 month postoperative visit. Patient reported satisfaction was also higher in the iDesign 2.0 cohort. The latest generation wavefront treatment produces better outcomes over those of yesteryear.