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



Sponsors


Source

National Eye Institute (NEI)

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.

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.

Overall Status

Unknown status

Start Date

1994-03-01

Completion Date

N/A

Primary Completion Date

N/A

Phase

Phase 2

Study Type

Interventional


Conditions


Intervention

Intervention Type

Device

Intervention Name



Eligibility

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.

Gender

All

Minimum Age

18 Years

Maximum Age

N/A


Location

Facility

National Institutes of Health
Bethesda Maryland 20892-1858 United States

Location Countries

Country

United States


Verification Date

1999-09-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Has Expanded Access

No

Condition Browse


Intervention Browse

Mesh Term

Calcium heparin

Heparin



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Primary Purpose

Treatment


Study First Submitted

September 23, 1999

Study First Submitted Qc

September 23, 1999

Study First Posted

September 24, 1999

Last Update Submitted

June 23, 2005

Last Update Submitted Qc

June 23, 2005

Last Update Posted

June 24, 2005

Last Known Status

Active, not recruiting


ClinicalTrials.gov processed this data on August 24, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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