Randomized Clinical Trial Comparing Implantable Collamer Lens Implantation (Icl V5) And Small-Incision Lenticule Extraction (Smile) Pro (Visumax 800)

To compare refractive predictability, efficacy, safety, and visual quality outcomes between implantable collamer lens implantation (ICL V5) and small-incision lenticule extraction (SMILE) Pro (VisuMax 800) for the treatment of myopia and myopic astigmatism.

Prospective, randomized, paired-eye, single-masked clinical trial. Consecutive eligible patients with stable myopia with or without astigmatism, in whom both eyes met eligibility criteria for both procedures, were enrolled at a single tertiary referral eye center. In each patient, one eye was randomized to undergo ICL V5 implantation and the fellow eye to undergo SMILE Pro.

For each participant, laterality (right/left) was randomized to receive ICL V5 implantation, with the contralateral eye undergoing SMILE Pro. ICL implantation (sphere or toric as indicated) was performed using a standard technique. SMILE Pro was performed using the VisuMax 800 femtosecond laser. Postoperative examinations were conducted at 1, 3, and 6 months and included manifest refraction, uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and adverse event recording. Patient-reported visual symptoms (e.g., halos/glare) and objective optical quality metrics (e.g., higher-order aberrations, contrast sensitivity) were assessed as secondary outcomes.

We recruited 50 consecutive patients (mean age, 28 ± 5 years; 68 % women; all Asian). Preoperative SE did not differ between eyes randomized to ICL V5 versus SMILE Pro (-5.35±1.75 diopters [D] vs. -5.32±1.76 D; P = 0.87). At 3 months, 98 % of ICL V5 eyes and 99 % of SMILE Pro eyes achieved SE within ±0.50 D of attempted correction (P = 0.89). UDVA of 20/20 or better was achieved in 98 % of ICL V5 eyes and 98 % of SMILE Pro eyes (P = 0.88). The efficacy index was 0.97±0.21 vs 0.98±0.20 (P = 0.56), and the safety index was 1.1±0.2 vs. 1.1±0.2 (P = 0.57). At 6 months, predictability, efficacy, and safety remained stable, with 98% vs 99% within ±0.50 D (P = 0.89) and 99% vs 99% achieving UDVA ≥20/20 (P = 0.58).

In this paired-eye randomized trial, both ICL V5 implantation and SMILE Pro (VisuMax 800) produced excellent refractive predictability, efficacy, and safety for myopia and myopic astigmatism at 3 and 6 months. Differences between procedures were primarily reflected in visual quality metrics and procedure-specific event profiles. These findings support individualized selection of lens-based versus corneal-based refractive correction according to ocular anatomy and patient priorities.