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

Sponsor
National Eye Institute (NEI) (NIH)
Overall Status
Unknown status
CT.gov ID
NCT00000119
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

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 DiseaseIntervention/TreatmentPhase
  • Device: Heparin Surface-Modified Intraocular Lens
Phase 2

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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Primary Purpose:
Treatment
Study Start Date :
Mar 1, 1994

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All

    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

    Locations

    SiteCityStateCountryPostal Code
    1National Institutes of HealthBethesdaMarylandUnited States20892-1858

    Sponsors and Collaborators

    • National Eye Institute (NEI)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00000119
    Other Study ID Numbers:
    • NEI-15
    First Posted:
    Sep 24, 1999
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Sep 1, 1999
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 24, 2005