A Retrospective Analysis of the Long-Term Safety and Efficacy of A1-UV Intraocular Lens Combined with Capsular Tension Ring in the Treatment of Patients with Cataract and Suspensory Ligament Abnormalities
Authors:   Eyebright Medical Technology (Beijing) Co., Ltd. Beijing, PR China, Yun Tian 
Published: November 2024

Objective: To evaluate the long-term safety and efficacy of the combination therapy of A1-UV Intraocular Lens (IOL) and Capsular Tension Ring (CTR) for cataract patients with abnormal suspensory ligaments. Method: Retrospective data analysis. Extract all patient information related to A1-UV IOL and 920H IOL from the existing Clinical Trial Database of CTR to form a new dataset. The new dataset focuses on IOL and the clinical safety and efficacy of A1-UV IOL and 920H IOL combined with CTR was compared and analyzed based on it. The follow-up time points include 1-2 days, 1 week, 1 month, 3 months, 6 months and 1 year. Evaluation indicators include Best-Corrected Distance Visual Acuity (BCDVA), Uncorrected Distance Visual Acuity (UCDVA), spherical power, cylindrical power, Equivalent Spherical power (SE), Intraocular Pressure (IOP), corneal endothelial cell density, inflammatory response, Adverse Events (AE) and Serious Adverse Events (SAE). Statistical analysis was conducted using SPSS 22.0 software. All statistical tests are conducted using a two-sided test, and a P-value less than 0.05 is considered statistically significant for the difference being tested. Compare the quantitative data using t-test or Wilcoxon rank-sum test. Compare count data using chi-square test or Fisher's exact probability. Results: The number of cases in the A1-UV group and 920H group were both 27 (monocular), with an average age of 68.46 ± 6.93 years old and 70.27 ± 10.95 years old, respectively. The sample sizes at 6 months and 1 year after surgery were 26 cases (96.30%) and 21 cases (77.77%) in the A1-UV group, respectively, while the 920H group consisted of 26 cases (96.30%) and 22 cases (81.48%), respectively. The use of two types of IOLs combined with CTRs can significantly improve BCDVA and UCDVA (both P<0.05). The differences between the groups during each follow-up period were not statistically significant (all P>0.05). The average residual spherical power, residual cylindrical power, and residual SE of both groups of patients after surgery were close to emmetropic eye. There was no statistically significant difference (P>0.05) in the comparison of other refraction indicators between the groups during each follow-up period, except for the cylindrical power at 3 months and 1 year after surgery. In the A1-UV group, a total of 2 patients experienced 3 episodes of mild IOP elevation, which was judged by the investigator to be unrelated to IOL, and no drug treatment was used, and it recovered spontaneously. 3 patients in the 920H group experienced three episodes of high IOP, including two mild cases (one possibly related to the IOL) and one moderate case (possibly related to the IOL), all of which were controlled by medication and recovered. In addition, the IOP of the remaining patients during each follow-up period after surgery was within the normal range. There was no AE or SAE related to implanted products in the A1-UV group. Conclusion: The combination of A1-UV IOL and CTR has long-term good safety and efficacy in the treatment of complex cataract patients with suspensory ligament abnormalities.