To investigate the safety and efficacy of a heparin surface-modified intraocular lens in
patients with uveitis undergoing cataract surgery.
To evaluate the safety and efficacy of intraocular lens implantation in patients with severe
Patients with uveitis are at high risk for significant complications following cataract
surgery with intraocular lens implantation. Complications may result from the surgery
itself or may develop after surgery as a result of the intraocular lens. Complications
related to intraocular lens implantation include iris adhesions to the intraocular lens,
which can result in lens capture; cellular deposits on the surface of the lens that can
obscure vision; and uveitis. Recent studies have identified giant cells on the anterior
surface of intraocular lenses in some patients with uveitis, appearing to indicate an
intraocular lens-induced inflammatory response. Some of these patients have required
multiple YAG laser procedures to remove these deposits.
Modification of the surface of the intraocular lens with a layer of heparin may provide a
more biocompatible surface. Preclinical studies have shown a reduction in the degree of
postoperative complications with the heparin surface-modified intraocular lens compared with
an unmodified lens. Although retrospective case series have examined the use of heparin
surface-modified intraocular lenses in patients with uveitis, a randomized, controlled
clinical trial has not been performed.
This is a randomized clinical trial examining the safety and efficacy of the heparin
surface-modified intraocular lens in patients with uveitis. Eighty patients with a history
of uveitis in an eye requiring cataract surgery will be randomized to receive a heparin
surface-modified intraocular lens or the same model of intraocular lens without surface
modification. The primary end point of the study will be the development of cellular
deposits on the anterior surface of the intraocular lens 1 year after surgery. These
cellular deposits will be assessed by a masked grader using standard photographs. Secondary
end points will include visual acuity, intraocular inflammation, development of anterior and
posterior synechiae, and corneal endothelial cell counts.
Women and men 18 years or older with a documented history of uveitis in an eye requiring
cataract surgery are eligible for the study. In all patients, the eye must be free of
active inflammation for at least 3 months before surgery, with or without
anti-inflammatory medications. Exclusion criteria include corneal pathology or hazy media
that preclude evaluation of the intraocular lens, uncontrolled glaucoma, and diabetes
mellitus. Monocular patients and patients who cannot be followed for at least 1 year are