Abstract
AIMS: To report on 4-year postoperative visual performance with the toric implantable collamer lens (TICL) for stable keratoconus after sequential procedure (corneal collagen crosslinking plus TICL implantation). METHODS: Forty eyes of 24 patients with stable keratoconus with myopia between 0.00 and -18.00 dioptres (D) and astigmatism between 1.25 and 8.00 D were evaluated in this prospective interventional study (https://clinicaltrials.gov/ct2/show/NCT02833649). We evaluated refraction, visual outcomes, astigmatic changes analysed by Alpins vector, contrast sensitivity, aberrometry, modulation transfer functions (MTFs), defocus curve, and operative and postoperative complications. RESULTS: At 4-year follow-up, 45% had 20/20 vision or better and 100% had 20/40 or better uncorrected visual acuity (UCVA). Vector analysis of refractive astigmatism shows that the surgically induced astigmatism (SIA) (3.20±1.46 D) was not significantly different from the target induced astigmatism (TIA) (3.14±1.42 D) (p=0.620). At 4 years postoperatively, none of the eyes showed a decrease in UCVA, in contrast to 24 eyes in which UCVA was increased by ≥1 lines, with contrast sensitivity and improvement in total aberrations and MTF value at 5 per degree (*p=0.004) after TICL implantation. The cumulative 4-year corneal endothelial cell loss was ≤5%. No patients reported dissatisfaction. At the end of follow-up, the vault was 658±54.33m (range, 500-711) and the intraocular pressure was 11.7±2.08 mm Hg. Occurrences of glare and night-driving troubles diminished after TICL surgery. CONCLUSION: The results from this standardised clinical investigation support TICL implantation from clinical and optical viewpoints in patients with stable keratoconus. TRIAL REGISTRATION NUMBER: NCT02833649, Pre-results.