[Evaluation of the safety and visual quality after implantation of the domestic made aspheric intraocular lens].

OBJECTIVE: To evaluate the safety and efficacy of the domestic foldable one-piece aspheric intraocular lens (IOL, Model: A1-UV) for the treatment of cataract. METHODS: A prospective randomized controlled clinical research were conducted. One hundred and nineteen cases (119 eyes) of cataract patients were randomly assigned to the study group (58 cases) and the control group (61 cases). The study group were implanted with the domestic made aspheric intraocular lens (Model: A1-UV) and the control group were implanted with imported aspheric intraocular lens (Model: SN60WF, Alcon Laboratories, Inc.). The visual acuity and the slit lamp examination were evaluated 1-2 day, 1 week, 1 month, 3 months, 6 months and 1 year postoperatively. In addition, the contrast sensitivity tests were carried out 3 months, 6 months and 1 year postoperatively. Data were analyzed by chi-square test and independent t-test. RESULTS: 100 patients had completed 1 year of follow-up, among which 49 cases were from the study group and 51 cases were from the control group. No severe inflammation or complications associated with intraocular lens were noted in either group within 1 year follow-up. The mean BCDVA, BCNVA, UCDVA, UCNVA(Log MAR) of the study group and the control group were 0.04±0.11, 0.11±0.17, 0.13±0.20, 0.35± 0.19 and 0.07±0.15, 0.15±0.20, 0.18±0.23, 0.41±0.21 at 1 year postoperatively. No statistically significant differences were noted between groups in mean BCDVA, BCNVA, UCDVA, UCNVA (t=-1.39, P=0.166; t=- 1.25, P=0.216; t=-1.06, P=0.292; t=-1.59, P=0.116) at 1 year postoperatively. And there was no significant difference in visual acuity between the two groups (P>0.05) 1-2 day, 1 week, 1 month, 3 months and 6 months postoperatively. The difference of the contrast sensitivity between the two groups was not statistically significant (P>0.05), besides the contrast sensitivity of the study group was significantly better than the control group at 12c/d, 18 c/d under bright light(t=2.18, P=0.031; t=2.67, P=0.009) at 3 months postoperatively. And the mean contrast sensitivity of the study group and the control group at 12c/d, 18 c/d under bright light were 1.31 ± 0.36, 0.86 ± 0.41 and 1.15 ± 0.40, 0.65 ± 0.44 at 3 months postoperatively. CONCLUSION: The safety and efficacy of the domestic made foldable one-piece aspheric intraocular lens (Model: A1-UV) for the treatment of cataract is equivalent to the imported aspheric intraocular lens (Model: SN60WF).