Rose K Sia1, Denise S Ryan2, Richard D Stutzman2, Joseph F Pasternak2, Jennifer B Eaddy2, Lorie A Logan2, Mark F Torres2, Kraig S Bower2. 1. From the Warfighter Refractive Eye Surgery Program and Research Center at Fort Belvoir (Sia, Ryan, Eaddy, Logan), Fort Belvoir, Virginia, the Ophthalmology Service (Stutzman, Pasternak), Walter Reed National Military Medical Center, Bethesda, Maryland, the Ophthalmology Service (Torres), Madigan Army Medical Center, Tacoma, Washington, and the Wilmer Eye Institute (Bower), Johns Hopkins University, Baltimore, Maryland, USA. Electronic address: rosekristine.c.sia.ctr@mail.mil. 2. From the Warfighter Refractive Eye Surgery Program and Research Center at Fort Belvoir (Sia, Ryan, Eaddy, Logan), Fort Belvoir, Virginia, the Ophthalmology Service (Stutzman, Pasternak), Walter Reed National Military Medical Center, Bethesda, Maryland, the Ophthalmology Service (Torres), Madigan Army Medical Center, Tacoma, Washington, and the Wilmer Eye Institute (Bower), Johns Hopkins University, Baltimore, Maryland, USA.
Abstract
PURPOSE: To compare visual outcomes following Visx Star S4 Customvue wavefront-guided and Allegretto Wave Eye-Q 400 Hz wavefront-optimized photorefractive keratectomy (PRK). SETTING: Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir, Virginia, and Walter Reed National Military Medical Center, Bethesda, Maryland, USA. DESIGN: Prospective randomized clinical trial. METHODS:Active-duty United States military soldiers were randomized to have wavefront-guided (Visx Star S4 Customvue) or wavefront-optimized PRK. Participants were followed up to 12 months postoperatively. Primary outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and manifest spherical equivalent (SE). Secondary outcome measures included refractive astigmatism, higher-order aberrations (HOAs), contrast sensitivity, subjective visual complaints, and patient satisfaction. RESULTS: The study evaluated 108 soldiers (mean age 30.3 years ± 6.3 [SD]; mean manifest SE -3.51 ± 1.63 D). At 12 months postoperatively, achieved UDVA, CDVA, manifest SE, and refractive astigmatism were comparable between wavefront-guided and wavefront-optimized groups (P > .213). Spherical aberration and total HOAs significantly increased from baseline in both groups (P < .006). The change in coma, trefoil, spherical aberration, and total HOAs (P > .254) were comparable between groups. There were fewer losses of photopic low-contrast visual acuity (LCVA) at 5% contrast after wavefront-guided compared to wavefront-optimized treatment (P = .003). There was no significant difference between treatment groups in visual symptoms, overall vision expectation, and satisfaction (P > .075). CONCLUSION: Wavefront-guided treatment offered a small advantage in photopic LCVA. Refractive outcomes, HOAs, self-reported visual difficulties, overall vision expectation, and satisfaction were otherwise comparable between wavefront-guided and wavefront-optimized treatments. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.
RCT Entities:
PURPOSE: To compare visual outcomes following Visx Star S4 Customvue wavefront-guided and Allegretto Wave Eye-Q 400 Hz wavefront-optimized photorefractive keratectomy (PRK). SETTING: Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir, Virginia, and Walter Reed National Military Medical Center, Bethesda, Maryland, USA. DESIGN: Prospective randomized clinical trial. METHODS: Active-duty United States military soldiers were randomized to have wavefront-guided (Visx Star S4 Customvue) or wavefront-optimized PRK. Participants were followed up to 12 months postoperatively. Primary outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and manifest spherical equivalent (SE). Secondary outcome measures included refractive astigmatism, higher-order aberrations (HOAs), contrast sensitivity, subjective visual complaints, and patient satisfaction. RESULTS: The study evaluated 108 soldiers (mean age 30.3 years ± 6.3 [SD]; mean manifest SE -3.51 ± 1.63 D). At 12 months postoperatively, achieved UDVA, CDVA, manifest SE, and refractive astigmatism were comparable between wavefront-guided and wavefront-optimized groups (P > .213). Spherical aberration and total HOAs significantly increased from baseline in both groups (P < .006). The change in coma, trefoil, spherical aberration, and total HOAs (P > .254) were comparable between groups. There were fewer losses of photopic low-contrast visual acuity (LCVA) at 5% contrast after wavefront-guided compared to wavefront-optimized treatment (P = .003). There was no significant difference between treatment groups in visual symptoms, overall vision expectation, and satisfaction (P > .075). CONCLUSION: Wavefront-guided treatment offered a small advantage in photopic LCVA. Refractive outcomes, HOAs, self-reported visual difficulties, overall vision expectation, and satisfaction were otherwise comparable between wavefront-guided and wavefront-optimized treatments. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.
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
Authors: Denise S Ryan; Rose K Sia; Jennifer B Eaddy; Lorie A Logan; Jide O Familoni; Hind Beydoun; Samantha B Rodgers; Bruce A Rivers Journal: Mil Med Res Date: 2020-01-16