Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000119
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-09-23
Brief Title:
Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
1999-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
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
To evaluate the safety and efficacy of intraocular lens implantation in patients with severe uveitis
Detailed Description:
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
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
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