Clinical context

Myopia studies should distinguish refractive change from axial elongation. The measures are related but not interchangeable, and their clinical meaning depends on age, baseline myopia and follow-up duration. Studies of progression control should also assess tolerability, adherence, rebound after treatment stops and potential adverse effects.

What was studied

VISUMAX 800 creates the lenticule faster and adds centration and cyclotorsion control. These features could improve astigmatic accuracy, but a technical upgrade does not guarantee clinical advantage. The review searched PubMed, EMBASE and the Cochrane Library through 22 February 2026 for direct comparisons with VISUMAX 500. The protocol was registered in PROSPERO and two reviewers selected and extracted studies.

How the evidence was produced

A meta-analysis combines several studies and can increase the precision of an overall estimate. Its conclusion still depends on the quality of the component studies, comparability of interventions and endpoints, statistical heterogeneity and publication bias. The pooled effect should be read with its confidence interval, sensitivity analyses and the reasons results differed across studies.

Key result Nine nonrandomized comparative studies published in 2024–2025 contributed 1,692 eyes: 1,036 treated with VISUMAX 500 and 656 with SMILE Pro. Follow-up ranged from one to six months. Uncorrected 20/20 or better was achieved by 95.6% and 94.1% of eyes, with pooled OR 0.90, 95% CI 0.43–1.85. Mean UDVA, spherical equivalent and most higher-order aberration measures did not differ significantly. SMILE Pro produced more accurate residual cylinder and a lower odds of losing corrected acuity lines, OR 0.47, 95% CI 0.25–0.86. Vector analysis suggested a tendency toward undercorrection with the older system and overcorrection with the newer platform.

How to interpret the result

The evidence does not establish broad visual superiority for VISUMAX 800. Better cylinder accuracy is biologically plausible because of cyclotorsion and centration control, but the clinical size of the difference is modest and depends on baseline astigmatism and nomogram. Workflow, laser time, comfort, suction-loss risk, surgeon experience and cost remain relevant platform considerations, yet they were incompletely assessed. Failure to detect a difference is not proof of formal equivalence.

The result should be understood as an estimate for the population studied, not a promise of an individual outcome. Statistical and clinical significance, absolute and relative effects, and prespecified and exploratory analyses should be distinguished. When several endpoints or subgroups are reported, the prespecified primary endpoint for which the study was designed usually provides the most reliable inference.

Clinical applicability

The findings apply most directly to patients who resemble participants in age, baseline refraction and rate of progression. Before selecting an intervention, check durability, the method used to measure axial length, completeness of follow-up and safety. A group average cannot predict the exact response of an individual child or adult.

Limitations

Every study was nonrandomized and follow-up was short. Myopia, astigmatism, operator experience and timing varied, with heterogeneity for several outcomes. Population overlap could not be excluded. Dry eye, dysphotopsia, biomechanics and epithelial remodeling were rarely evaluated. Verify GRADE ratings, line-loss definitions, the absolute cylinder difference, sensitivity analyses, funding, conflicts and baseline comparability.

Beyond the limitations acknowledged by the authors, confidence is affected by sample size, follow-up duration, missing data, choice of comparator and relevance of the outcomes to routine care. Uncommon complications may remain undetected even in a well-conducted study. External validity is reduced when participants, equipment or investigator expertise differ substantially from everyday settings.

What to verify in the source

In the full paper, verify the protocol, eligibility criteria, baseline group characteristics, primary endpoint definition, confidence intervals, adverse events and losses to follow-up. Funding, conflicts of interest, trial registration and consistency between the published analysis and the original plan deserve separate attention. The DOI or source link below provides access to the primary publication for this check.