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
- toric implantable collamer lens (TICL)
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Original reference: None
Contributors AS, FD and SN: collected patient data and wrote the manuscript. FD and FN: concept and study design. FD: critical evaluation of the manuscript. FD, ABR and MG: clinical evaluation for severity of addictions. CA: statistical analysis.
Competing interests None declared.
Patient consent Obtained.
Ethics approval Tehran University of Medical Sciences.
Provenance and peer review Not commissioned; externally peer reviewed.
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