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CLINICAL TRIAL
CLINICAL TRIAL, PHASE III
COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
Surgically induced astigmatism after photorefractive keratectomy and laser in situ keratomileusis. Summit PRK-LASIK Study Group.
Journal of Cataract and Refractive Surgery 1999 March
PURPOSE: To compare the axis and magnitude of surgically induced astigmatism in photorefractive keratectomy (PRK) and laser in situ keratomileusis (LASIK).
SETTING: Multicenter clinical trial.
METHODS: In this prospective randomized trial, 220 eyes of 220 patients entered the study cohort: 105 randomized to PRK and 115 to LASIK. All patients received a single-pass, multizone excimer laser ablation as part of a PRK or LASIK procedure. Attempted corrections ranged from -6.00 to -15.00 diopters (D). The LASIK procedures were performed with nasal hinges. Absolute changes in astigmatism and axis and magnitude of surgically induced astigmatism were analyzed. Patients were followed for up to 6 month.
RESULTS: In the PRK group, the mean change in absolute astigmatism was +0.14, +0.16 and +0.32 D at 1, 3, and 6 months, respectively; in the LASIK group, the mean change was -0.15, -0.08, and -0.03 D, respectively. At all time points, a greater proportion of PRK than LASIK eyes had an increase in absolute magnitude of astigmatism. In the PRK group, the axis of vectoral-induced astigmatism was significantly different from random at 3 and 6 months (P = .01, P < .001), respectively) with a tendency for induced with-the-rule shifts postoperatively. In the LASIK group, the axis of vectoral-induced astigmatism was significantly different from random at only 1 month (P = .04), and there was no preponderant direction of axis shift. Despite these findings, other analyses showed no statistically significant between-group differences in vectoral axis or magnitude of surgically induced astigmatism.
CONCLUSIONS: Induced astigmatism was generally less and more random in axis in LASIK than in PRK; a general trend for induced with-the-rule astigmatism in PRK was not seen in LASIK. Hypothetically, the lamellar corneal flap in LASIK may counteract the tendency toward steepening at 90 degrees seen in PRK by retracting toward the hinge, by masking underlying induced astigmatism in the ablation zone, or by its mitigating influence on postoperative corneal healing.
SETTING: Multicenter clinical trial.
METHODS: In this prospective randomized trial, 220 eyes of 220 patients entered the study cohort: 105 randomized to PRK and 115 to LASIK. All patients received a single-pass, multizone excimer laser ablation as part of a PRK or LASIK procedure. Attempted corrections ranged from -6.00 to -15.00 diopters (D). The LASIK procedures were performed with nasal hinges. Absolute changes in astigmatism and axis and magnitude of surgically induced astigmatism were analyzed. Patients were followed for up to 6 month.
RESULTS: In the PRK group, the mean change in absolute astigmatism was +0.14, +0.16 and +0.32 D at 1, 3, and 6 months, respectively; in the LASIK group, the mean change was -0.15, -0.08, and -0.03 D, respectively. At all time points, a greater proportion of PRK than LASIK eyes had an increase in absolute magnitude of astigmatism. In the PRK group, the axis of vectoral-induced astigmatism was significantly different from random at 3 and 6 months (P = .01, P < .001), respectively) with a tendency for induced with-the-rule shifts postoperatively. In the LASIK group, the axis of vectoral-induced astigmatism was significantly different from random at only 1 month (P = .04), and there was no preponderant direction of axis shift. Despite these findings, other analyses showed no statistically significant between-group differences in vectoral axis or magnitude of surgically induced astigmatism.
CONCLUSIONS: Induced astigmatism was generally less and more random in axis in LASIK than in PRK; a general trend for induced with-the-rule astigmatism in PRK was not seen in LASIK. Hypothetically, the lamellar corneal flap in LASIK may counteract the tendency toward steepening at 90 degrees seen in PRK by retracting toward the hinge, by masking underlying induced astigmatism in the ablation zone, or by its mitigating influence on postoperative corneal healing.
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