Four-year postoperative results of the US ALLEGRETTO WAVE clinical trial for the treatment of hyperopia.
To evaluate the long-term refractive stability after LASIK for hyperopia with the WaveLight ALLEGRETTO WAVE Excimer Laser System.



All 151 patients enrolled in the 2000-2002 FDA study of the ALLEGRETTO WAVE laser were contacted by the investigators approximately 4 years after study completion to be evaluated for refractive stability.



A total of 127/290 (43.8%) eyes in 68/151 (45%) patients presented for re-examination. Mean time from the examination taken at the 6-month follow-up stability endpoint in the FDA trial (Stability Exam) to the Post-Approval Exam was 3.9+/-0.39 years (range: 3.2 to 4.9 years). Stability of the manifest refraction spherical equivalent (MRSE) within +/-1.00 D or less was seen in 119/127 (93.7%) eyes. Regression of effect of >1.00 D was seen in 6/127 (4.7%) eyes and progression of effect was seen in 2/127 (1.6%) eyes. Weak correlation of refractive changes with keratometry readings were seen in eyes that underwent >2.00 to 4.00 D treatment (R=0.31) and >4.00 D treatment (R=0.33), implying corneal remodeling may have played a role in the refractive change observed.



Refractive stability within +/-1.00 D MRSE after hyperopic LASIK with the ALLEGRETTO WAVE excimer laser was seen in 93.7% of eyes at > or =3 years after surgery compared with 6-month follow-up, supporting the conclusion in the FDA trial that refractive stability occurred by 6 months postoperatively. Refractive changes associated with keratometry changes were not significant in eyes that underwent < or =2.00-D treatment.
Kezirian
Guy M
GM
SurgiVision Consultants Inc, Scottsdale, AZ 85262, USA. Guy1000@SurgiVision.net
Moore
Charles R
CR
Stonecipher
Karl G
KG
D000328:Adult; D000368:Aged; D019781:Corneal Topography; D005260:Female; D006801:Humans; D006956:Hyperopia / Q000503:physiopathology / Q000601:surgery*; D020731:Keratomileusis, Laser In Situ / Q000379:methods*; D054018:Lasers, Excimer; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration; D014792:Visual Acuity / Q000502:physiology