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Modified Intraocular Lens to Reduce Eye Inflammation After Cataract Surgery in Uveitis Patients

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ClinicalTrials.gov Identifier: NCT00001311
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:

This study will test the effectiveness of an intraocular lens treated with heparin in reducing or preventing inflammation after cataract surgery in patients with uveitis.

Patients with uveitis (inflammatory eye disease) often develop cataracts (clouding of the lens of the eye) that can impair eyesight. Cataracts can be removed surgically, and this is usually done when poor vision interferes with adequate daily functioning, or when the lens becomes too cloudy to evaluate the level of eye inflammation in uveitis-information needed to adjust medication dosages. After surgery, vision is corrected with special eyeglasses, contact lenses, or intraocular lenses (IOL). IOLs are small, plastic artificial lenses permanently placed inside the eye.

Patients with uveitis who require cataract surgery and whose eye inflammation has been controlled by medicine for at least 3 months may be eligible for this study. Those enrolled in the study will be randomly assigned to one of two treatment groups: one group will have a standard IOL implanted during cataract surgery; the other will receive a heparin-treated IOL.

Before surgery, patients will undergo standard preoperative tests, including chest X-ray, electrocardiogram, blood tests and urinalysis, as well as an eye examination that includes photography of the cornea, iris and retina. Additional tests and examinations to be done at the start of the study and at periodic follow-up visits for about 1 year may include: fluorescein angiography to evaluate the blood vessels of the retina; specular microscopy to examine the surface of the IOL; cell and flare measurements to evaluate inflammation, and ultrasound to examine the back of the eye.


Condition or disease Intervention/treatment Phase
Cataracts Device: heparin-surface modified intraocular lens Phase 2

Detailed Description:
The purpose of this project is to evaluate the ability of a heparin-surface modified intraocular lens to reduce the incidence and severity of post-operative inflammation in patients with uveitis undergoing extracapsular cataract surgery. Patients who have a history of uveitis and have been in remission on steroids and/or cyclosporine or cytotoxic agents for at least three months will be considered for this study. They will be randomized in a masked fashion to either a surface-modified lens or to a non-modified lens of similar design. The intraocular inflammation will be assessed using standardized clinical criteria, and by a laser cell flare meter at those sites using this equipment. The presence of inflammatory cells on the lens surface will be assessed using specular micrography. In an initial period, the study will only be carried out in the Clinical Center of the National Eye Institute (NEI) at the National Institutes of Health (NIH). However, in order to complete the study in a reasonable period of time, it may be expanded to include several outside centers.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of a Surface Modified Intraocular Lens in Reducing Post-Operative Inflammatory Signs Following Extracapsular Surgery in Uveitis Patients With Cataracts
Study Start Date : April 1992
Estimated Study Completion Date : February 2001

Resource links provided by the National Library of Medicine

Drug Information available for: Heparin
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Follow-up Only.
Contacts and Locations

Information from the National Library of Medicine

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): NCT00001311


Locations
United States, Maryland
National Eye Institute (NEI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Eye Institute (NEI)
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001311     History of Changes
Other Study ID Numbers: 920157
92-EI-0157
First Posted: December 10, 2002    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: March 2000

Keywords provided by National Institutes of Health Clinical Center (CC):
Cell/Flare Meter
Heparin Coating
Inflammation
Laser Cell Flare Photometry
Multicentric
Polymethylmetacrylate
Specular Micrography
Specular Microscopy

Additional relevant MeSH terms:
Cataract
Uveitis
Lens Diseases
Eye Diseases
Uveal Diseases
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action