Three-Year Follow-Up On The Safety And Efficacy Of Cross-Linked Polyisobutylene (Xpib) Aspherical Iols

To evaluate long term safety and effectiveness of an IOL made of cross-linked polyisobutylene, a novel biomaterial for new generation of foldable IOLs, at three-year postoperative follow up. 

Xian Eyedeal Medical Technology, Inc. Ltd

188 subjects from the original prospective, multicenter, parallel-controlled, randomized clinical trial were recalled for a 3 year follow up visit. Subjects were originally enrolled in 1:1 ratio with either cross-linked polyisobutylene (xPIB) IOL (test group) or Acrysof SN60WF IOL (control group) implantation. UCDVA, BCDVA, slit lamp and fundus findings, IOP, ECD, IOL stability, device deficiency were evaluated. An investigator-administered patient satisfactory questionnaire was documented. Major parameters between two groups were statistically compared.  

95 (48 in test group and 47 in control group) out of the original 188 subjects completed 3-year follow up. Average BCDVA was 0.875 and 0.868 (Snellen Decimals) in test and control group, respectively. The difference between predicted and residual refractive error was 0.056D (test) and 0.147D (control). Glistenings were observed in 14 subjects (29.8%) in the control group, whereas none was in the test group. PCO was observed in 12 subjects (25%) in the test group and 20 subjects (42.6%) in the control group. No Nd:YAG laser capsulotomy was reported. Subjects in both groups reported satisfaction with their implants and none or minimal needs of glasses for distance vision. Glare and halos were noticed more in the control group than test group.

At the 3-year postoperative follow-up, the IOL made of cross-linked polyisobutylene (xPIB) demonstrated excellent long-term safety and effectiveness. The clinical results showed clear advantage of no glistenings and lower incidence of PCO at 3-year post-implantation, compared with control IOL.