IMPORTANCE: Wavefront-guided (WFG) and wavefront-optimized (WFO) platforms for refractive surgery are designed for improved visual outcomes. It is unclear which treatment profile is superior for patients undergoing photorefractive keratectomy (PRK). OBJECTIVE: To compare the safety, efficacy, predictability, stability, and higher-order aberrations in eyes undergoing WFG and WFO PRK. DESIGN, SETTING, AND PARTICIPANTS: A prospective, randomized, fellow-eye-controlled clinical trial was conducted at the Byers Eye Institute at Stanford with enrollment between April 2009 and March 2011; 1 year of follow-up was included. Of 90 patients screened, 71 patients (142 eyes) with less than 12.00 diopters (D) of spherical myopia and less than 3.00 D of astigmatism were enrolled consecutively. INTERVENTIONS: One eye was randomized to undergo WFG PRK treatment (Visx CustomVue Star S4 IR excimer laser system; Abbott Medical Optics), and the fellow eye received WFO PRK treatment (WaveLight Allegretto Wave Eye-Q 400 Hz excimer laser system; Alcon Surgical). MAIN OUTCOMES AND MEASURES: Data on the manifest refraction, uncorrected visual acuity, best-corrected visual acuity, 5% and 25% contrast best-corrected visual acuity, and higher-order aberrations were collected preoperatively and at the 1-, 3-, 6-, and 12-month follow-up visits. RESULTS: Eyes undergoing both treatments had improved best-corrected visual acuity (WFG: mean, 0.05 [95% CI, 0.03-0.07]; WFO: mean, 0.04 [95% CI, 0.02-0.06]) and less sphere (WFG: mean, -4.79 [95% CI, -5.31 to -4.26]; WFO: mean, -4.61 [95% CI, -5.18 to -4.03]), cylinder (WFG: mean, 0.66 [95% CI, 0.49-0.82]; WFO: mean, 0.52 [95% CI, 0.35-0.69]), and spherical equivalents (WFG: mean, -4.45 [95% CI, -4.99 to -3.91]; WFO: mean, -4.34 [95% CI, -4.92 to -3.76]) (P < .001) but higher levels of spherical aberration (WFG: mean, -0.11 [95% CI, -0.15 to -0.06]; WFO: mean, -0.11 [95% CI, -0.14 to -0.07]) (P < .001) and higher-order root-mean-square aberrations (WFO: mean, -0.07 [95% CI, -0.12 to -0.02]; WFO: mean, -0.12 [95% CI, -0.17 to -0.70]) (P = .005 in WFG eyes and P < .001 in WFO eyes) at 12 months compared with preoperative measurements. A total of 93.0% of the eyes in the WFG group and 94.4% in the WFO had an uncorrected visual acuity of 20/20 or better at 12 months, with 56.3% in the WFG group and 43.7% in the WFO group gaining 1 or more lines of best-corrected visual acuity. The stability of the refractive correction was excellent for both groups. CONCLUSIONS AND RELEVANCE: A difference in uncorrected visual acuity or contrast acuity between eyes undergoing WFG or WFO treatment at 3 months and beyond could not be identified. This lack of difference suggests that both systems can be used to provide excellent improvement in vision for persons with myopia. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01135719.
RCT Entities:
IMPORTANCE: Wavefront-guided (WFG) and wavefront-optimized (WFO) platforms for refractive surgery are designed for improved visual outcomes. It is unclear which treatment profile is superior for patients undergoing photorefractive keratectomy (PRK). OBJECTIVE: To compare the safety, efficacy, predictability, stability, and higher-order aberrations in eyes undergoing WFG and WFO PRK. DESIGN, SETTING, AND PARTICIPANTS: A prospective, randomized, fellow-eye-controlled clinical trial was conducted at the Byers Eye Institute at Stanford with enrollment between April 2009 and March 2011; 1 year of follow-up was included. Of 90 patients screened, 71 patients (142 eyes) with less than 12.00 diopters (D) of spherical myopia and less than 3.00 D of astigmatism were enrolled consecutively. INTERVENTIONS: One eye was randomized to undergo WFG PRK treatment (Visx CustomVue Star S4 IR excimer laser system; Abbott Medical Optics), and the fellow eye received WFO PRK treatment (WaveLight Allegretto Wave Eye-Q 400 Hz excimer laser system; Alcon Surgical). MAIN OUTCOMES AND MEASURES: Data on the manifest refraction, uncorrected visual acuity, best-corrected visual acuity, 5% and 25% contrast best-corrected visual acuity, and higher-order aberrations were collected preoperatively and at the 1-, 3-, 6-, and 12-month follow-up visits. RESULTS: Eyes undergoing both treatments had improved best-corrected visual acuity (WFG: mean, 0.05 [95% CI, 0.03-0.07]; WFO: mean, 0.04 [95% CI, 0.02-0.06]) and less sphere (WFG: mean, -4.79 [95% CI, -5.31 to -4.26]; WFO: mean, -4.61 [95% CI, -5.18 to -4.03]), cylinder (WFG: mean, 0.66 [95% CI, 0.49-0.82]; WFO: mean, 0.52 [95% CI, 0.35-0.69]), and spherical equivalents (WFG: mean, -4.45 [95% CI, -4.99 to -3.91]; WFO: mean, -4.34 [95% CI, -4.92 to -3.76]) (P < .001) but higher levels of spherical aberration (WFG: mean, -0.11 [95% CI, -0.15 to -0.06]; WFO: mean, -0.11 [95% CI, -0.14 to -0.07]) (P < .001) and higher-order root-mean-square aberrations (WFO: mean, -0.07 [95% CI, -0.12 to -0.02]; WFO: mean, -0.12 [95% CI, -0.17 to -0.70]) (P = .005 in WFG eyes and P < .001 in WFO eyes) at 12 months compared with preoperative measurements. A total of 93.0% of the eyes in the WFG group and 94.4% in the WFO had an uncorrected visual acuity of 20/20 or better at 12 months, with 56.3% in the WFG group and 43.7% in the WFO group gaining 1 or more lines of best-corrected visual acuity. The stability of the refractive correction was excellent for both groups. CONCLUSIONS AND RELEVANCE: A difference in uncorrected visual acuity or contrast acuity between eyes undergoing WFG or WFO treatment at 3 months and beyond could not be identified. This lack of difference suggests that both systems can be used to provide excellent improvement in vision for persons with myopia. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01135719.
Authors: Isabel Rodríguez-Pérez; Juan Gros-Otero; Miguel A Teus; Rafael Cañones; Montserrat García-González Journal: BMC Ophthalmol Date: 2019-10-15 Impact factor: 2.209
Authors: Khaled M Hamam; Mohamed I Gbreel; Randa Elsheikh; Amira Y Benmelouka; Yassamine Ouerdane; Amr K Hassan; Aboalmagd Hamdallah; Ahmed B Elsnhory; Anas Z Nourelden; Ahmed T Masoud; Asmaa A Ali; Khaled M Ragab; Ahmed M Ibrahim Journal: Indian J Ophthalmol Date: 2020-12 Impact factor: 1.848