|
Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis Clinical research trials and Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis. Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis clinical trial. Subjects frequently obtain the most expert healthcare possible for their Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis  Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis
Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis
For Condition: Cataract,Uveitis
Status: No longer recruiting
Sponsor(s): National Eye Institute (NEI) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
National Institutes of Health
Bethesda, Maryland, 20892-1858
United States
Additional Information:
Study ID Numbers: NEI-15;
Study Start Date: March 1994
Record last reviewed: September 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000119
Other Uveitis Studies:
1. The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated with Juvenile Rheumatoid Arthritis
2. Vascular Endothelial Growth Factor (VEGF) in Uveitis
3. Effect of Pregnancy on Uveitis
4. Leflunomide to Treat Uveitis
5. ANTI-TAC THERAPY FOR UVEITIS
Related Studies:
Other Uveitis Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis
|
|
|
|
|
|
|
|
