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Peer-reviewedCC BY-NC 4.0Clinical Ophthalmology (Auckland, N.Z.)

Three-Month Ocular Surface and Dry-Eye Outcomes After Implantable Collamer Lens (ICL) Implantation versus Small-Incision Lenticule Extraction (SMILE): A Prospective Non-Randomized Comparative Cohort Study

  1. 1Department of Refractive Surgery, Guangzhou Panyu Aier Eye Hospital, Guangzhou, 511400, People’s Republic of China
  2. 2Department of Refractive Surgery, Guangzhou Aier Eye Hospital, Guangzhou, 510010, People’s Republic of China

Abstract

Purpose: To compare ocular surface and dry-eye parameters 3 months after implantable collamer lens (ICL) implantation vs small-incision lenticule extraction (SMILE).

Patients and Methods: Right eyes of 98 patients with complete data (SMILE, n = 49; ICL, n = 49) were analyzed. Ocular Surface Disease Index (OSDI), non-invasive tear meniscus height (NITMH), non-invasive tear-film break-up time (NIBUT), ocular redness index (ORI), corneal fluorescein staining (CFS), refraction and visual acuity were measured before and 3 months after surgery. Between-group comparisons of change from baseline were the primary analysis. Sensitivity ANCOVA models adjusted for the corresponding baseline value, preoperative spherical equivalent refraction (SEQ), age, sex and surgeon; CFS was analyzed using binary logistic regression for any staining (CFS > 0).

Results: ICL eyes were more myopic (preoperative SEQ −6.47 ± 2.16 vs −4.55 ± 1.27 D; P < 0.001); baseline dry-eye parameters were similar, although small differences in CDVA and IOP were present. At 3 months, uncorrected and corrected distance visual acuity were comparable (P = 0.300 and 0.498). Between-group comparisons of change from baseline showed no statistically significant difference for NIBUT (−0.22 s; 95% CI −3.10 to 2.67; P = 0.881), NITMH, ORI, CFS or OSDI. In the sensitivity analysis, the baseline-adjusted between-group difference in 3-month NIBUT was −1.68 s (95% CI −4.01 to 0.64; P = 0.153). The adjusted odds of any staining (CFS) tended to be lower in the ICL group, but the difference did not reach statistical significance (odds ratio 0.33; 95% CI 0.11–1.01; P = 0.052) and should be considered exploratory.

Conclusion: In this non-randomized comparison of patients with clinically normal preoperative ocular surface who received standardized postoperative lubrication, no statistically significant between-group differences were detected for the primary tear-film outcome NIBUT or for NITMH, ORI or OSDI at 3 months. The lower odds of any corneal staining after ICL were exploratory and require further confirmation.

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BibTeX
@article{du2026threemonth,
  title = {{Three-Month Ocular Surface and Dry-Eye Outcomes After Implantable Collamer Lens (ICL) Implantation versus Small-Incision Lenticule Extraction (SMILE): A Prospective Non-Randomized Comparative Cohort Study}},
  author = {Huiyi Du and Huiqing Zhang and Anqi Yuan and Lu Xiong},
  journal = {Clinical Ophthalmology (Auckland, N.Z.)},
  year = {2026},
  month = oct,
  doi = {10.2147/opth.s654384},
  url = {https://doi.org/10.2147/opth.s654384},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - Three-Month Ocular Surface and Dry-Eye Outcomes After Implantable Collamer Lens (ICL) Implantation versus Small-Incision Lenticule Extraction (SMILE): A Prospective Non-Randomized Comparative Cohort Study
AU  - Huiyi Du
AU  - Huiqing Zhang
AU  - Anqi Yuan
AU  - Lu Xiong
PY  - 2026
DA  - 2026/10/30
JO  - Clinical Ophthalmology (Auckland, N.Z.)
DO  - 10.2147/opth.s654384
UR  - https://doi.org/10.2147/opth.s654384
AB  - Purpose: To compare ocular surface and dry-eye parameters 3 months after implantable collamer lens (ICL) implantation vs small-incision lenticule extraction (SMILE).  Patients and Methods: Right eyes of 98 patients with complete data (SMILE, n = 49; ICL, n = 49) were analyzed. Ocular Surface Disease Index (OSDI), non-invasive tear meniscus height (NITMH), non-invasive tear-film break-up time (NIBUT), ocular redness index (ORI), corneal fluorescein staining (CFS), refraction and visual acuity were measured before and 3 months after surgery. Between-group comparisons of change from baseline were the primary analysis. Sensitivity ANCOVA models adjusted for the corresponding baseline value, preoperative spherical equivalent refraction (SEQ), age, sex and surgeon; CFS was analyzed using binary logistic regression for any staining (CFS > 0).  Results: ICL eyes were more myopic (preoperative SEQ −6.47 ± 2.16 vs −4.55 ± 1.27 D; P < 0.001); baseline dry-eye parameters were similar, although small differences in CDVA and IOP were present. At 3 months, uncorrected and corrected distance visual acuity were comparable (P = 0.300 and 0.498). Between-group comparisons of change from baseline showed no statistically significant difference for NIBUT (−0.22 s; 95% CI −3.10 to 2.67; P = 0.881), NITMH, ORI, CFS or OSDI. In the sensitivity analysis, the baseline-adjusted between-group difference in 3-month NIBUT was −1.68 s (95% CI −4.01 to 0.64; P = 0.153). The adjusted odds of any staining (CFS) tended to be lower in the ICL group, but the difference did not reach statistical significance (odds ratio 0.33; 95% CI 0.11–1.01; P = 0.052) and should be considered exploratory.  Conclusion: In this non-randomized comparison of patients with clinically normal preoperative ocular surface who received standardized postoperative lubrication, no statistically significant between-group differences were detected for the primary tear-film outcome NIBUT or for NITMH, ORI or OSDI at 3 months. The lower odds of any corneal staining after ICL were exploratory and require further confirmation.
SN  - 1177-5467
SN  - 1177-5483
ER  -