PURPOSE: To evaluate the long-term refractive stability after LASIK for hyperopia with the WaveLight ALLEGRETTOWAVE Excimer Laser System. METHODS:All 151 patients enrolled in the 2000-2002 FDA study of theALLEGRETTO WAVE laser were contacted by the investigators approximately 4 years after study completion to be evaluated for refractive stability. RESULTS: 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. CONCLUSIONS:Refractive stability within +/-1.00 D MRSE after hyperopic LASIK with the ALLEGRETTOWAVE 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.
RCT Entities:
PURPOSE: To evaluate the long-term refractive stability after LASIK for hyperopia with the WaveLight ALLEGRETTO WAVE Excimer Laser System. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors: Majid Moshirfar; Alin Megerdichian; William B West; Chase M Miller; Ronald Alek Sperry; Calvin D Neilsen; Mitchell T Tingey; Phillip C Hoopes Journal: Ophthalmol Ther Date: 2021-05-19
Authors: Andreas Frings; Gisbert Richard; Johannes Steinberg; Vasyl Druchkiv; Stephan Johannes Linke; Toam Katz Journal: Clin Ophthalmol Date: 2016-03-31