Comparative analysis of the visual performance after implantation of the toric implantable collamer lens in stable keratoconus: a 4-year follow-up after sequential procedure (CXL+TICL implantation)

Farideh Doroodgar, Feazollah Niazi, Azad Sanginabadi, Sana Niazi, Alireza Baradaran-Rafii, Cyrus Alinia, Eznollah Azargashb, Mohammad Ghoreishi, Farideh Doroodgar, Feazollah Niazi, Azad Sanginabadi, Sana Niazi, Alireza Baradaran-Rafii, Cyrus Alinia, Eznollah Azargashb, Mohammad Ghoreishi

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://ichgcp.net/clinical-trials-registry/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.

Keywords: cross-linking; keratoconus; toric implantable collamer lens (TICL).

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Eligibility assessment procedure. CDVA, corrected distance visual acuity; CXL, corneal collagen crosslinking; TICL, toric implantable collamer lens.
Figure 2
Figure 2
A comparison of preoperative best corrected distance visual acuity and postoperative uncorrected distance visual acuity 4 years after toric implantable collamer lens. UCVA, uncorrected visual acuity.
Figure 3
Figure 3
Postoperative spherical equivalent during follow-up (1 year and 4 years).
Figure 4
Figure 4
Log MAR (logarithm of the minimum angle of resolution) visual acuity defocus curve of +2, +1, 0, −1, −2, −3 and −4 D in a non-cycloplegic condition in the preoperative and postoperative.
Figure 5
Figure 5
(A) Contrast sensitivity under mesopic illumination (3 cd/m2). *Statistically significantly different at a level of 0.05. (B) Contrast sensitivity under photopic illumination (85 cd/m2).
Figure 6
Figure 6
Total and corneal aberrations in 40 eyes with keratoconus before and after undergoing toric implantable collamer lens surgery. *Statistically significantly different at a level of 0.05. RMS, root mean square,
Figure 7
Figure 7
Vectorial display of the difference vector during postoperative follow-up.
Figure 8
Figure 8
MTF pre-TICL and post-TICL implantation.

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