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Peer-reviewedCC BY 4.0Journal of Clinical Medicine

Comparison of Treatment Zone Decentration Between VISUMAX 500 and VISUMAX 800 Keratorefractive Lenticule Extraction Using Anterior Segment Optical Coherence Tomography

  1. 1Hangil Eye Hospital, Incheon 21388, Republic of Korea
  2. 2Bright St. Mary Eye Clinic (BSM Eye Clinic), Seoul 06232, Republic of Korea
  3. 3Department of Ophthalmology, Catholic Kwandong University College of Medicine, Incheon 22711, Republic of Korea

Abstract

Background/Objectives: To compare treatment-zone decentration after small-incision lenticule extraction (SMILE) performed with VISUMAX 500 and VISUMAX 800 using corneal thickness difference maps derived from anterior segment optical coherence tomography. Methods: This retrospective comparative study included 44 eyes of 22 participants who underwent SMILE with VISUMAX 500 or VISUMAX 800 by a single surgeon and had preoperative and 3-month postoperative CASIA2 examinations. Treatment-zone centers were primarily identified manually relative to the corneal vertex. Between-platform differences were analyzed using generalized estimating equations (GEE) accounting for inter-eye correlation, with additional adjustment for preoperative cylinder. Participant-level analyses and semi-automated radial color-symmetry localization were performed as sensitivity analyses. Results: Twenty-two eyes of 11 participants were included in each group. Mean radial decentration was 0.219 ± 0.134 mm with VISUMAX 500 and 0.225 ± 0.171 mm with VISUMAX 800. The mean between-group difference was 0.006 mm (95% confidence interval [CI], −0.074 to 0.085; p = 0.890), and remained similar after adjustment for preoperative cylinder (0.006 mm; 95% CI, −0.082 to 0.094; p = 0.888). Participant-level analysis likewise showed no evidence of a between-group difference (mean difference, 0.0056 mm; 95% CI, −0.083 to 0.094; exact permutation p = 0.907). Reanalysis using semi-automated localization yielded a similarly small between-platform difference (0.0114 mm; 95% CI, −0.063 to 0.086; p = 0.763). Conclusions: In this small single-surgeon cohort, treatment-zone decentration did not differ significantly between VISUMAX 500 and VISUMAX 800. The findings were consistent across participant-level and semi-automated sensitivity analyses. Because the study was not designed as an equivalence or noninferiority trial, these results should be interpreted as an absence of evidence for a between-platform difference rather than evidence of equivalent centration performance.

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BibTeX
@article{yoo2026comparison,
  title = {{Comparison of Treatment Zone Decentration Between VISUMAX 500 and VISUMAX 800 Keratorefractive Lenticule Extraction Using Anterior Segment Optical Coherence Tomography}},
  author = {Tae Keun Yoo and Si-Hoon Park and Sang-Mok Lee},
  journal = {Journal of Clinical Medicine},
  year = {2026},
  month = oct,
  doi = {10.3390/jcm15207851},
  url = {https://www.mdpi.com/2077-0383/15/20/7851},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Comparison of Treatment Zone Decentration Between VISUMAX 500 and VISUMAX 800 Keratorefractive Lenticule Extraction Using Anterior Segment Optical Coherence Tomography
AU  - Tae Keun Yoo
AU  - Si-Hoon Park
AU  - Sang-Mok Lee
PY  - 2026
DA  - 2026/10/01
JO  - Journal of Clinical Medicine
DO  - 10.3390/jcm15207851
UR  - https://www.mdpi.com/2077-0383/15/20/7851
AB  - Background/Objectives: To compare treatment-zone decentration after small-incision lenticule extraction (SMILE) performed with VISUMAX 500 and VISUMAX 800 using corneal thickness difference maps derived from anterior segment optical coherence tomography. Methods: This retrospective comparative study included 44 eyes of 22 participants who underwent SMILE with VISUMAX 500 or VISUMAX 800 by a single surgeon and had preoperative and 3-month postoperative CASIA2 examinations. Treatment-zone centers were primarily identified manually relative to the corneal vertex. Between-platform differences were analyzed using generalized estimating equations (GEE) accounting for inter-eye correlation, with additional adjustment for preoperative cylinder. Participant-level analyses and semi-automated radial color-symmetry localization were performed as sensitivity analyses. Results: Twenty-two eyes of 11 participants were included in each group. Mean radial decentration was 0.219 ± 0.134 mm with VISUMAX 500 and 0.225 ± 0.171 mm with VISUMAX 800. The mean between-group difference was 0.006 mm (95% confidence interval [CI], −0.074 to 0.085; p = 0.890), and remained similar after adjustment for preoperative cylinder (0.006 mm; 95% CI, −0.082 to 0.094; p = 0.888). Participant-level analysis likewise showed no evidence of a between-group difference (mean difference, 0.0056 mm; 95% CI, −0.083 to 0.094; exact permutation p = 0.907). Reanalysis using semi-automated localization yielded a similarly small between-platform difference (0.0114 mm; 95% CI, −0.063 to 0.086; p = 0.763). Conclusions: In this small single-surgeon cohort, treatment-zone decentration did not differ significantly between VISUMAX 500 and VISUMAX 800. The findings were consistent across participant-level and semi-automated sensitivity analyses. Because the study was not designed as an equivalence or noninferiority trial, these results should be interpreted as an absence of evidence for a between-platform difference rather than evidence of equivalent centration performance.
SN  - 2077-0383
ER  -