Abstract:

Objective To evaluate the clinical efficacy and safety of the domestic CTR model capsular tension ring for cataract surgery to maintain capsular tension. Design Multicenter, randomized, open, positive and parallel controlled clinical studies. Participants 119 cataract patients aged over 18 years and with grade 1-3 cataract nuclear hardness, which need to maintain capsular tension. Methods Participants were randomly assigned to the study group (59 cases) or the control group (60 cases). The phacoemulsification and the implantation of a capsular tension ring and intraocular lenses (IOL) were performed. The subjects in study group were implanted with the domestic CTR model capsular tension ring (Eyebright Medical Technology (Beijing) Co., Ltd., China), while the subjects in control group were implanted with a TENSIOBAG model capsular tension ring (Carl Zeiss Medical Technology Co., Ltd., Germany). Follow-up evaluation at 1~2 days, 1 week, 1 month, 3 months, 6 months, and 1 year or above after surgery. Statistical analysis was performed using t-test, Wilcoxon rank sum test, chi-square test, CMH chi-square test, exact probability test, and exact probability method to compare the efficacy and safety between the two groups. Main Outcome Measures The best corrected distant visual acuity(BCDVA), uncorrected distant visual acuity(UCDVA), diopter, postoperative IOL decentration, capsule contraction and the counts of corneal endothelial cells. Results At all the follow-up times after the operation, there was no statistically significant difference between the two groups (all P>0.05) in the BCDVA, the UCDVA and their changes from the baseline. At 6 months and 1 year after the operation, there was no statistically significant difference between the two groups (all P>0.05) in the diopter and the changes from the baseline. There was no statistically significant difference between the two groups (all P>0.05) in IOL decentration. In the study group, no IOL decentration was found at 1-2 days, 1 week, 1 month, 3 months and 1 year or above after the operation; one case with slightly decentration was found at 6-month visit but the IOL centered at 1-year-or-above visit. No IOL decentration was found in the control group at all the follow-ups. There was no capsule contraction in the two groups during the follow-up period. In terms of safety, there was no statistically significant difference between the two groups (all P>0.05) in the results of slit lamp examination and intraocular pressure at the follow-ups and no pupillary blockage was found. There was no significant difference between the two groups (all P>0.05) in corneal endothelial cell density at 1 year or above after the operation. Conclusion The efficacy and safety of  domestic CTR model capsular tension ring (Eyebright Medical Technology (Beijing) Co., Ltd., China) for capsular tension maintenance in cataract surgery is comparable to TENSIOBAG model capsular tension ring (Carl Zeiss Medical Technology Co., Ltd., Germany).

Key words: capsular tension ring, cataract, intraocular lens, effectiveness, safety