Efficacy of Heparin Surface-modified IOLs in Reducing Postoperative Inflammatory Reactions in Patients with Exfoliation Syndrome — a Double-blind Comparative Study

OBJECTIVE: The objective of the study was to evaluate the effect of heparin surface modification of intraocular lenses (HSM IOLs) on postoperative inflammatory reactions in cataract patients with exfoliation syndrome. The primary efficacy variables were the presence on the lens surface of giant cells determined from specular microscopy photographs and the presence of cell deposits determined by slit-lamp. STUDY DESIGN: Prospective, randomized, double-blind clinical study with a follow-up period of 6 months. PATIENTS: The study comprised 58 patients who were randomized into 2 groups: 31 patients received polymethylmethacrylate (PMMA) lenses and 27 patients received HSM lenses. The mean age in the HSM group was 78.1 years and the mean age in the PMMA group was 78.3 years. RESULTS: Giant cells on the lens surface were found in more patients in the PMMA group at all postoperative visits. At 6 months the difference between the groups was statistically significant (P = 0.023). The maximal density of giant cells patient was significantly greater in the PMMA group compared to the HSM group at 1, 3 and 6 months postoperatively (P ≤ 0.05). Cell deposits, assessed by slit lamp, were observed in fewer patients in the HSM group (vs. PMMA) at 1 and 3 months. At 6 months 69% (11/16) of the patients in the HSM group and 84% (21/25), in the PMMA group had a best corrected visual acuity of 0.5 or better. This difference was not statistically significant (P = 0.25). Overall, the number of postoperative complications was lout. At 6 months no complications were reported. CONCLUSION: The postoperative inflammatory reaction as determined by the presence of giant cells and cell deposits on the lens surface is significantly reduced by heparin surface modification of the IOL in patients with exfoliation syndrome.