Ignite Creation Date:
2024-05-06 @ 9:01 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02873026
Status:
COMPLETED
Last Update Posted:
2021-09-17
First Post:
2016-06-13
Brief Title:
Adjunctive Steroid Combination in Ocular Trauma ASCOT Study
Sponsor:
Moorfields Eye Hospital NHS Foundation Trust
Organization:
Moorfields Eye Hospital NHS Foundation Trust
Study Overview
Official Title:
A Phase 3 Multi-centre Double-masked Randomised Controlled Trial of Adjunctive Intraocular and Periocular Steroid Triamcinolone Acetonide Versus Standard Treatment in Eyes Undergoing Vitreoretinal Surgery for Open Globe Trauma
Status:
COMPLETED
Status Verified Date:
2021-09
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:
ASCOT
Brief Summary:
Eye trauma is a leading cause of blindness and visual impairment Penetrating injuries of the eye are more likely to result in poor vision and the main cause of this is a scarring response on the retina proliferative vitreoretinopathy PVR The purpose of this study is to investigate the potential of an anti-inflammatory treatment triamcinolone acetonide to improve the outcome of surgery in eyes that have suffered severe traumaThere is good evidence from laboratory studies that additional steroid treatment into and around the eye at the time of surgery could reduce scarring by reducing inflammation and improve visual outcomes
Detailed Description:
Trauma is an important cause of visual impairment and blindness worldwide and a leading cause of blindness in young adult malesGlobally it has been estimated that 16 million people are blind as a result of ocular trauma with 23 million suffering bilateral low vision Ocular trauma is the commonest cause of unilateral blindness in the world today with up to 19 million with unilateral blindness or low vision It is estimated that almost one million people in the United States live with trauma-related visual impairment Ocular trauma has extensive socio-economic costs - patients with open globe injuries lose a mean of 70 days of work In the United States work related eye injuries cost over 300 million per year wwwprevent blindnessorg this equates to an annual cost to the UK economy for which no comparable data exists of 375 million
In the UK it is estimated that 5000 patients per year sustain eye injuries serious enough to require hospital admission and of these 250 will be permanently blinded in the injured eye Recent European studies document incidences of 24 and 32 per 100000 per year for open-globe injuries which suggests an annual incidence for the UK of between 1500 and 2000
Ocular injuries which result in visual loss invariably affect the posterior segment of the eye and prevention of visual loss involves posterior segment vitreoretinal surgery It is clear from recent published data that although vitreoretinal surgical techniques have improved outcomes remain unsatisfactory and that development of the intraocular scarring response proliferative vitreoretinopathy PVR is the leading cause of this
In the UK it is estimated that 5000 patients per year sustain eye injuries serious enough to require hospital admission and of these 250 will be permanently blinded in the injured eye Recent European studies document incidences of 24 and 32 per 100000 per year for open-globe injuries which suggests an annual incidence for the UK of between 1500 and 2000
Ocular injuries which result in visual loss invariably affect the posterior segment of the eye and prevention of visual loss involves posterior segment vitreoretinal surgery It is clear from recent published data that although vitreoretinal surgical techniques have improved outcomes remain unsatisfactory and that development of the intraocular scarring response proliferative vitreoretinopathy PVR is the leading cause of this
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