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

NCT00001311 | Completed Phase 2

• 2 other identifiers: 92015792-EI-0157
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataracts

Keywords

Cell/Flare Meter; Heparin Coating; Inflammation; Laser Cell Flare Photometry; Multicentric; Polymethylmetacrylate; Specular Micrography; Specular Microscopy

Interventions

heparin-surface modified intraocular lens DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Follow-up Only.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Ohara K. Biomicroscopy of surface deposits resembling foreign-body giant cells on implanted intraocular lenses. Am J Ophthalmol. 1985 Mar 15;99(3):304-11. doi: 10.1016/0002-9394(85)90360-5.

  PMID: 3883790 BACKGROUND

• Wolter JR. Foreign body giant cells selectively covering haptics of intraocular lens implants: indicators of poor toleration? Ophthalmic Surg. 1983 Oct;14(10):839-44.

  PMID: 6364004 BACKGROUND

• Shah SM, Spalton DJ, Smith SE. Measurement of aqueous cells and flare in normal eyes. Br J Ophthalmol. 1991 Jun;75(6):348-52. doi: 10.1136/bjo.75.6.348.

  PMID: 2043578 BACKGROUND

MeSH Terms

Conditions

Cataract; Inflammation

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: April 1, 1992
• Study Completion: February 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2000-03

Locations

US (1)