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Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 1999 by National Eye Institute (NEI).   Recruitment status was  Active, not recruiting

First Received on September 23, 1999.   Last Updated on June 23, 2005   History of Changes
Sponsor: 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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

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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

No publications provided

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

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

ClinicalTrials.gov processed this record on February 12, 2012