Heparin Surface-modified IOLs Compared with Regular PMMA IOLs in Patients with Diabetes and/or Glaucoma — 1 year Results of a Double-Blind Randomized Multi-independent Trial

Abstract

OBJECTIVE: The objective of the study was to compare the inflammatory reaction following cataract surgery in patients with diabetes and/or glaucoma implanted with heparin surface modified (HSM) or PMMA intraocular lenses (IOLs). Specular microphotography and slit lamp evaluation were used to determine the presence of foreign body giant cells and cellular deposits on the IOL surface. The presence of capsular fibrosis, pigment and fibrin or fibrinlike deposits determined by slit lamp were secondary efficacy variables. STUDY DESIGN: The study was performed as a prospective, randomized, double-blind, multi-independent clinical trial with 1 year follow-up. PATIENTS: The study comprised 239 patients with diabetes and/or glaucoma. Of these patients, 122 had diabetes, 103 patients had glaucoma, and 14 patients had both diabetes and glaucoma. The mean age of the patients was 73 (± 9.8) years. RESULTS: At all visits, including the 1 year visit, there was a statistically significant difference in favour of HSM with a lower percentage of patients having giant cells on the IOL surface in the HSM group. Cellular deposits, seen with the slit lamp, were also found in significantly fewer patients in the HSM group at all follow-up visits except at 1 week. Visual acuity, at 1 year, was ≥ 0.5 (20/40) in 72% of the HSM group and in 84% of the PMMA group. The reason for a visual acuity below 0.5 was in most cases related to preoperative pathologies, especially in the diabetic patients in the HSM group. CONCLUSION: The results of this study indicate that heparin surface modification increases the biocompatibility of PMMA IOLs by significantly reducing the postoperative foreign body reaction for at least 1 year following cataract surgery in patients with diabetes and/or glaucoma.