Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001311
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Modified Intraocular Lens to Reduce Eye Inflammation After Cataract Surgery in Uveitis Patients
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2000-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 92-EI-0157 | None | None | None |