| Purpose: To verify the long-term safety,effectiveness and predictability of the central hole phakic intraocular lens(ICL V4c)in correcting high myopia and high myopia with astigmatism,and the long-term stability of toric ICL(TICL)in correcting astigmatism.Methods: This study is a retrospective non-randomized clinical trial.Forty-two patients(80 eyes)with high myopia and high myopia with astigmatism who underwent ICL V4 c implantation in the Third People ’s Hospital of Da Lian from September 2015 to September 2016 were selected,including 20 patients(38 eyes)with toric ICL V4 c implantation and 22 patients(42 eyes)with non-toric ICL V4 c implantation.The patients were followed up for 5 years after operation.The data of patients before operation,1 month after operation and 5 years after operation were observed and collected,including spherical diopter,cylindrical diopter,astigmatism axis,equivalent spherical diopter,uncorrected visual acuity,best corrected visual acuity,safety index(postoperative best corrected visual acuity/preoperative best corrected visual acuity),effective index(postoperative uncorrected visual acuity/ preoperative best corrected visual acuity),intraocular pressure,corneal endothelial cell density,vault.The astigmatism data were analyzed by Alpins vector analysis method and Assort calculator,and the expected corrected astigmatism vector(TIA),surgical corrected astigmatism vector(SIA),error vector(DV),correction ratio(CI)and error angle(Ao E)were obtained.Repeated measures analysis of variance was used to compare the preoperative and postoperative eye parameters at different time points.Paired sample t test was used to compare the postoperative measurement data between the two groups.Pearson correlation test was used for statistical analysis.Results: The spherical degrees of TICL and ICL groups decreased from 0.61 ± 0.36 D and 0.44 ± 0.43 D at 1 month after operation to 0.33 ± 0.57 D and 0.19 ± 0.44 D at 5years after operation,respectively.There were significant differences between the two time points(P< 0.05).Compared with preoperative,the axial length of the two groups increased by 0.12 ± 0.15 mm and 0.09 ± 0.16 mm,respectively,and the change of spherical diopter was positively correlated with the axial length(P< 0.05).At 5 years after surgery,there was no significant difference in uncorrected visual acuity,best corrected visual acuity and spherical equivalent between the two groups(P>0.05).The safety indices of TICL group was better than that of ICL group(P< 0.05),and there was no significant difference in effecacy indices between the two groups(P>0.05).BCVA loss of 2 lines or more in the TICL group did not occur.2 eyes(5.3 %)lost 1 line,14 eyes(36.8 %)had no change,20 eyes(52.6 %)increased 1 line,2 eyes(5.3 %)increased 2 lines.In patients receiving ICL,BCVA loss of 2 lines or more did not occur.There were 2 eyes(4.8 %)lost one line,20 eyes(47.6 %)unchanged,20eyes(47.6 %)increased one line,and no increase in two lines or more.In patients receiving TICL,the proportion of spherical equivalent within 0,±0.5D,±1.0D and±2.0D was 21.1%,84.2%,92.1% and 100%,respectively.In patients receiving ICL,the proportion of spherical equivalent within 0,± 0.5D,± 1.0D and ± 2.0D was 19.0 %,73.8 %,89.0 % and 100 %,respectively.The mean residual astigmatism of the TICL group was-0.71 ± 0.72 D at 1 month after operation and-0.90 D ± 0.43 D at 5 years after operation.The difference was statistically significant(P< 0.05).The average TIA vector was 2.06 D × 178°,the average SIA vector was 1.27 D × 174°,the average DV vector was 0.81 D × 3°,and the CI was 0.66.The Ao E ≤ 5°in 20 eyes,Ao E ≤ 15°in 34 eyes,and Ao E > 15°in4 eyes.There was no significant difference in intraocular pressure between the two groups before operation,1 month after operation and 5 years after operation(P> 0.05),and there was no significant difference between the two groups at each time point(P>0.05).The difference of corneal endothelial cell density between the two groups before and 5 years after operation was statistically significant(P< 0.05).The vault of TICL group at 1 month and 5 years after operation was 614.37 ± 193.89μm and 505.00 ±172.99μm,respectively,and the difference between the two time points was statistically significant(P<0.001).The vault of ICL group was 590.60 ± 212.39μm and 475.60 ±182.30μm at 1 month and 5 years after operation,respectively.The difference between the two time points was statistically significant(P< 0.001).There was no significant difference between the two groups at each time point(P> 0.05).The decrease of vault was positively correlated with the vault at 1 month after operation(P< 0.05),and was slightly correlated with the size of ICL V4 c lens(P< 0.05).In this study,it was found that 1 eye had mild anterior subcapsular opacity after surgery,and 1 eye had macular retinoschisis after surgery.There were no complications such as cataract,glaucoma,corneal decompensation,pigment blocks central hole during follow-up.Conclusion: 1.The TICL and the ICL are safety and effective with good predictability at 5 years after correction of refractive error,and the incidence of complications was extremely low.However,long-term follow-up still needed to observe the decrease of corneal endothelial cell density,the change of vault and the progress of axial length.2.The best corrected visual acuity improved more after TICL implantation.Although the effect of correcting astigmatism has an undercorrection trend,the safety index and effective index are ideal,but the visual quality still needs attention. |
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