Effect of heparin-surface-modified intraocular lenses on postoperative inflammation after phacoemulsification: a randomized trial in a United States patient population. Heparin-Surface-Modified Lens Study Group.

OBJECTIVE: To compare postoperative inflammation occurring with heparin-surface-modified (HSM) versus non-HSM polymethyl methacrylate intraocular lenses (IOLs) after phacoemulsification.
DESIGN: Randomized, double-masked, multicenter, parallel trial. PARTICIPANTS: A total of 367 patients, consisting of routine (n = 220), glaucoma (n = 58), and diabetes (n = 89) patients, from eight US medical centers.
METHODS: Patients were observed for 1 year after phacoemulsification and lens implantation (week 1, months 1, 3, 6, 12). MAIN OUTCOME MEASURES: Primary measures of postoperative inflammation defined as the presence of giant cells on the lens surface via specular micrography and cellular deposits via slit-lamp examination.
RESULTS: The cross-sectional analyses showed that consistently fewer routine patients with HSM lens implants had giant cells on the IOL than those with non-HSM lens implants across all follow-up visits. The statistical significance (P < 0.05) was observed at all visits except month 12 for routine patients. The diabetes patients also demonstrated the same giant cell difference, and the statistical significance was observed at all visits including month 12. A similar trend was also observed in the glaucoma patients, with statistical significance only at the 3-month visit. For cell deposits, significant differences in favor of the HSM lens (P < 0.05) were observed at 3 months among routine and diabetes patients, and at 3 and 6 months among glaucoma patients. A longitudinal data analysis using the generalized estimating equation approach indicated statistically significant treatment effect of HSM lenses in reducing inflammation in all patients except for cellular deposits in diabetes patients. In all patient groups, sight-threatening complications were not reported either more frequently or with more severity than normally expected for patients who have undergone cataract extraction and IOL implantation.
CONCLUSIONS: The present study, the only one to have used phacoemulsification in virtually all patients (211/220 [96%] routine, 57/58 [98%] glaucoma, and 84/89 [94%] diabetes) is the largest to evaluate and compare concurrently routine, glaucoma, and diabetes patients. It is also the first US patient population study to document that heparin surface modification reduces postoperative inflammatory responses, as measured by specular micrography and slit-lamp examination, especially in the early postoperative period.

RCT Entities:   Population Interventions Outcomes