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Randomized Controlled Trial
. 2011 Dec:109:201-20.

Wavefront-guided laser in situ keratomileusis (Lasik) versus wavefront-guided photorefractive keratectomy (Prk): a prospective randomized eye-to-eye comparison (an American Ophthalmological Society thesis)

Affiliations
Randomized Controlled Trial

Wavefront-guided laser in situ keratomileusis (Lasik) versus wavefront-guided photorefractive keratectomy (Prk): a prospective randomized eye-to-eye comparison (an American Ophthalmological Society thesis)

Edward E Manche et al. Trans Am Ophthalmol Soc. 2011 Dec.

Abstract

Purpose: To compare the safety and efficacy of wavefront-guided laser in situ keratomileusis (LASIK) vs photorefractive keratectomy (PRK) in a prospective randomized clinical trial.

Methods: A cohort of 68 eyes of 34 patients with -0.75 to -8.13 diopters (D) of myopia (spherical equivalent) were randomized to receive either wavefront-guided PRK or LASIK in the fellow eye using the VISX CustomVue laser. Patients were evaluated at 1 day, 1 week, and months 1, 3, 6, and 12.

Results: At 1 month, uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), 5% and 25% contrast sensitivity, induction of higher-order aberrations (HOAs), and subjective symptoms of vision clarity, vision fluctuation, ghosting, and overall self-assessment of vision were worse (P<0.05) in the PRK group. By 3 months, these differences had resolved (P>0.05). At 1 year, mean spherical equivalent was reduced 94% to -0.27 ± 0.31 D in the LASIK group and reduced 96% to -0.17 ± 0.41 D in the PRK group. At 1 year, 91% of eyes were within ±0.50 D and 97 % were within ±1.0 D in the PRK group. At 1 year, 88% of eyes were within ±0.50 D and 97% were within ±1.0 D in the LASIK group. At 1 year, 97% of eyes in the PRK group and 94% of eyes in the LASIK group achieved an UCVA of 20/20 or better (P=0.72). Refractive stability was achieved in both PRK and LASIK groups after 1 month. There were no intraoperative or postoperative flap complications in the LASIK group. There were no instances of corneal haze in the PRK group.

Conclusions: Wavefront-guided LASIK and PRK are safe and effective at reducing myopia. At 1 month postoperatively, LASIK demonstrates an advantage over PRK in UCVA, BSCVA, low-contrast acuity, induction of total HOAs, and several subjective symptoms. At postoperative month 3, these differences between PRK and LASIK results had resolved.

Trial registration: ClinicalTrials.gov NCT01140594.

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Figures

FIGURE 1
FIGURE 1
Percentage of eyes within ±0.50 (diopters) D and ±1.0 D of attempted correction for the phtorefractive keratectomy (PRK) and laser in situ keratomileusis (LASIK) groups at 1 month, 3 months, 6 months, and 12 months following their procedure.
FIGURE 2
FIGURE 2
Attempted vs achieved correction (mean spherical equivalent, diopters) for the LASIK and PRK groups at the 12 month-postoperative visit. In the LASIK group 88% of eyes were within ±0.5 D of attempted correction and 97% of eyes were within ±1.0 D of attempted correction. In the PRK group 91% of eyes were within ±0.5 D of attempted correction and 97% were within ±1.0 D of attempted correction.
FIGURE 3
FIGURE 3
Mean spherical equivalent (diopters) over each of the postoperative periods. Refractive stability was achieved at 1 month for both LASIK and PRK groups. Standard error bars are shown.
FIGURE 4
FIGURE 4
Uncorrected visual acuity (UCVA, logMAR, mean) for LASIK and PRK groups for each postoperative interval. Standard error bars are shown.
FIGURE 5
FIGURE 5
Percentage of eyes with the designated uncorrected visual acuity (UCVA) at each postoperative interval for both the LASIK and PRK groups.
FIGURE 6
FIGURE 6
Best spectacle-corrected visual acuity (BSCVA) (logMAR, mean) for LASIK and PRK groups for each postoperative interval. Standard error bars are shown.
FIGURE 7
FIGURE 7
Change in best spectacle-corrected visual acuity (BSCVA; number of lines) at 12 months postoperatively. The percentage of eyes (%) is demonstrated for the LASIK and PRK groups. No eyes in the LASIK or PRK groups lost more than 1 line of BSCVA.
FIGURE 8
FIGURE 8
Best spectacle-corrected visual acuity (logMAR, mean) for LASIK and PRK groups for each postoperative interval under 5% contrast conditions. Standard error bars are shown.
FIGURE 9
FIGURE 9
Best spectacle-corrected visual acuity (logMAR, mean) for LASIK and PRK groups for each postoperative interval under 25% contrast conditions. Standard error bars are shown.
FIGURE 10
FIGURE 10
Higher-order aberrations, root-mean-square (RMS, μm) over each of the designated postoperative intervals for the LASIK and PRK groups. Standard error bars are shown.
FIGURE 11
FIGURE 11
Glare symptoms for each of the designated postoperative intervals for LASIK and PRK eyes during the day and night. Standard error bars are shown.
FIGURE 12
FIGURE 12
Haze symptoms for each of the designated postoperative intervals for LASIK and PRK eyes. Standard error bars are shown.
FIGURE 13
FIGURE 13
Halo symptoms for each of the designated postoperative intervals for LASIK and PRK eyes. Standard error bars are shown.
FIGURE 14
FIGURE 14
Vision clarity symptoms for each of the designated postoperative intervals for LASIK and PRK eyes during the night and day. Standard error bars are shown.
FIGURE 15
FIGURE 15
Frequency and severity of dry eye symptoms for each of the designated postoperative intervals for LASIK and PRK eyes. Standard error bars are shown.
FIGURE 16
FIGURE 16
Gritty and scratchy symptoms for each of the designated postoperative intervals for LASIK and PRK eyes. Standard error bars are shown.
FIGURE 17
FIGURE 17
Fluctuation of vision symptoms for each of the designated postoperative intervals for LASIK and PRK eyes. Standard error bars are shown.
FIGURE 18
FIGURE 18
Ghosting symptoms for each of the designated postoperative intervals for LASIK and PRK eyes. Standard error bars are shown.
FIGURE 19
FIGURE 19
Self-assessment of overall vision for each of the designated postoperative intervals for LASIK and PRK eyes. “0” was described as “excellent” vision.

References

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