One-year natural course of corneal densitometry in high myopic patients after implantation of an implantable collamer lens (model V4c)

Abstract

Abstract Background Corneal densitometry, which is also known as corneal backscattering, is a surrogate measure of corneal clarity. The purpose of the study was to investigate the changes in corneal densitometry (CD) after implanting an implantable collamer lens (ICL-V4c). Method Twenty-six high myopic patients (aged 29.3 ± 6.6 years, 6 males and 20 females) who underwent ICL-V4c implantation were enrolled. Intraocular pressure (IOP), corneal topography, corneal densitometry, uncorrected distance visual acuity (UCDVA), manifest refraction, and best corrected distance visual acuity (BCDVA) were evaluated pre-operatively and at 1 day, 1 week, and 1, 3, 6, and 12 months post-operatively. Endothelial cell density (ECD) was measured pre-operatively and at 3, 6, and 12 months post-operatively. The efficacy index (mean post-operative UCDVA / mean pre-operative BCDVA) and the safety index (mean post-operative BCDVA / mean pre-operative BCDVA) were evaluated at 1 month, 3 months, 6 months and 12 months post-operatively. Results Over the annular diameters of 0–2 mm, the pre-operative densitometry values of the anterior layer, central layer, posterior layer, and total layer were 20.1 ± 2.8, 11.8 ± 1.1, 10.5 ± 0.9 and 14.1 ± 1.5, respectively. From pre-operatively to post-operative Month 12, the values changed insignificantly (P = 0.177, P = 0.153, P = 0.543 and P = 0.207, respectively). Over the annular diameters of 2–6 mm, the pre-operative mean densitometry values were 17.9 ± 2.2, 10.5 ± 0.9, and 12.6 ± 1.2, respectively. From pre-operatively to post-operative Month 12, the values decreased to 16.5 ± 2.1, 10.0 ± 0.9, and 11.9 ± 1.2, respectively, which were similar to the pre-operative values (all P > 0.05) but significantly lower than the values obtained at post-operative Day 1 (P = 0.013, P = 0.002 and P = 0.010, respectively). The densitometry value of the posterior layer over the annular diameters of 2 to 6 mm remained unchanged (from 9.4 ± 0.7 to 9.1 ± 0.7) over time (P = 0.372). The efficacy and safety indices assessed at 12 months post-operatively were 1.04 ± 0.27 and 1.19 ± 0.23, respectively. The changes in IOP and ECD values were statistically insignificant (P = 0.896 and P = 0.968, respectively). Conclusion ICL-V4c implantation may be safe and efficient for high ametropia correction. The corneal densitometry values obtained over the annulus of 0–6 mm increased slightly from before the operation to post-operative Day 1 and then decreased gradually, which indicates that ICL-V4c implantation may not compromise corneal clarity.