Original Articles
Prospective, Randomized Contralateral Eye Comparison of Wavefront-Guided Laser In Situ Keratomileusis and Small Incision Lenticule Extraction Refractive Surgeries

https://doi.org/10.1016/j.ajo.2021.11.013Get rights and content

Purpose

Wavefront-guided laser in situ keratomileusis (WFG-LASIK) and small incision lenticule extraction (SMILE) are keratorefractive surgeries that can improve uncorrected visual acuity in myopic patients. Comparison of visual outcomes in myopic patients treated with LASIK and SMILE is needed.

Design

Prospective, randomized contralateral eye-controlled trial.

Methods

We performed a single-center prospective, randomized contralateral eye comparison of WFG-LASIK and SMILE (NCT03067077). Myopic patients with low levels of astigmatism were treated with WFG-LASIK in one eye and SMILE in the fellow eye from March 2017 to March 2021. Treatments were randomized by ocular dominance. WFG-LASIK and SMILE were performed. Postoperative evaluation at 1 day consisted of uncorrected distance visual acuity (UDVA), wavefront aberrometry, and a slit-lamp examination. On subsequent postoperative visits at 1 month, 3 months, 6 months, and 12 months, UDVA, manifest refraction, 5% and 25% low-contrast visual acuity, wavefront aberrometry, and slit-lamp examination were performed. Main outcome measure: The primary outcome measure was UDVA at 12 months.

Results

Eighty-eight eyes of 44 patients with myopia were enrolled in the study. Seventy-four eyes of 37 patients had successful treatments and completed 12 months of follow-up. At postoperative month 12, there were a significantly higher proportion of WFG-LASIK eyes that had ≥20/20 UDVA compared with SMILE eyes (94% vs 83%, P < .05). There was no difference between spherical equivalent between WFG-LASIK eyes and SMILE eyes (−0.17 ± 0.25 vs −0.29 ± 0.38, P > .05); there was no difference in higher order aberrations, including coma, trefoil, and spherical aberrations (P > 0.05); and there were a significantly higher proportion of WFG-LASIK eyes that had improved 5% and 25% low-contrast visual acuity compared with SMILE eyes (P < 0.05).

Conclusions

WFG-LASIK and SMILE both offered marked improvements in corrected distance visual acuity and excellent predictability in both eyes. Compared with SMILE, WFG-LASIK resulted in faster visual recovery, better low-contrast visual acuity, and greater gains in uncorrected visual acuity.

Section snippets

SUBJECTS AND METHODS

This single-center prospective, randomized contralateral eye-controlled study was approved by the institutional review board/ethics committee of Stanford University, and the trial was registered at clinicaltrials.gov (NCT03067077). The study adhered to the tenets of the Declaration of Helsinki. Myopic patients with and without astigmatism were enrolled in the prospective WFG-LASIK vs SMILE study after informed consent was obtained. After determining ocular dominance by the Dolman method7 and

RESULTS

Eighty-eight eyes of 44 patients with myopia were enrolled in the study starting in March 2017, and the study was completed in March 2021. See the CONSORT flowchart for detailed description of subject disposition (Figure 1). Three patients withdrew from the study before having surgery, and 1 patient had aborted SMILE surgery because of difficulty removing the lenticule. Results are presented for 80 eyes of 40 patients who had surgery and were able to follow up. The patient population included

DISCUSSION

The results from our prospective, randomized contralateral eye study comparing WFG-LASIK and SMILE yielded excellent visual outcomes in both treatment groups. The primary outcome of the study was uncorrected visual acuity at 12 months, and WFG-LASIK resulted in significantly better visual acuity at all postoperative visits compared with SMILE. WFG-LASIK resulted in faster visual recovery compared with SMILE. This effect was not due to overcorrection or undercorrection as a higher proportion of

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    Gabriel S. Valerio is currently practicing at Department of Ophthalmology, Naval Medical Center San Diego, University of California, San Diego, California, USA.

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