Adjunctive Steroid Combination in Ocular Trauma (ASCOT) Study (ASCOT)
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|ClinicalTrials.gov Identifier: NCT02873026|
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Eye Injury Trauma||Drug: Triamcinolone Acetonide||Phase 3|
Trauma is an important cause of visual impairment and blindness worldwide and a leading cause of blindness in young adult males.Globally it has been estimated that 1.6 million people are blind as a result of ocular trauma with 2.3 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 (www.prevent blindness.org) this equates to an annual cost to the UK economy (for which no comparable data exists) of £37.5 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 2.4 and 3.2 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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.|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
No Intervention: Standard care
The patient will receive the standard care given to all patients that have received a vitrectomy following open globe trauma.
Experimental: Triamcinolone acetonide
Triamcinolone Acetonide 4mg/0.1ml intravitreal cavity and 40mg/1ml subtenons to be injected at the time of the vitrectomy. Patients will then receive standard care following operation.
Drug: Triamcinolone Acetonide
Following the repair of the open globe eye trauma, the use of Triamcinolone Acetonide will be investigated
Other Name: kenalog
- Improvement of visual acuity at 6 months [ Time Frame: 6 months ]The proportion of patients with an improvement from baseline to 6 months of at least 10 on the corrected visual acuity in the study eye (total ETDRS letter score measured at 4 metres and 1 metre)
- Total visual acuity score at 6 months [ Time Frame: 6 months ]Total EDTRS score in the study eye at the 6 months follow up appointment
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): NCT02873026
|Contact: Elizabeth Robertson, Phd||0207 firstname.lastname@example.org|
|Moorfields Eye Hospital||Recruiting|
|London, United Kingdom|
|Principal Investigator: David G Charteris, MD|
|Principal Investigator:||David Charteris, MD||Moorfields Eye Hosptial|