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Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis

This study is ongoing, but not recruiting participants.

Sponsored by: National Eye Institute (NEI)
Information provided by: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT00000119
  Purpose

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 Intervention Phase
Cataract
Uveitis
Device: Heparin Surface-Modified Intraocular Lens
Phase II

MedlinePlus related topics:   Cataract   

ChemIDplus related topics:   Heparin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized

Further study details as provided by National Eye Institute (NEI):

Study Start Date:   March 1994

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

Criteria

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 also excluded.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000119

Locations
United States, Maryland
National Institutes of Health    
      Bethesda, Maryland, United States, 20892-1858

Sponsors and Collaborators
  More Information


Study ID Numbers:   NEI-15
First Received:   September 23, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00000119
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Uveitis
Eye Diseases
Cataract
Lens Diseases
Heparin
Calcium heparin

Additional relevant MeSH terms:
Fibrin Modulating Agents
Uveal Diseases
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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