Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis
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|ClinicalTrials.gov Identifier: NCT00000119|
Recruitment Status : Unknown
Verified September 1999 by National Eye Institute (NEI).
Recruitment status was: Active, not recruiting
First Posted : September 24, 1999
Last Update Posted : June 24, 2005
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 uveitis.
|Condition or disease||Intervention/treatment||Phase|
|Cataract Uveitis||Device: Heparin Surface-Modified Intraocular Lens||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Study Start Date :||March 1994|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000119
|United States, Maryland|
|National Institutes of Health|
|Bethesda, Maryland, United States, 20892-1858|