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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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|
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
|United States, Maryland|
|National Eye Institute (NEI)|
|Bethesda, Maryland, United States, 20892|