A Phase 3 interventional study of Triamcinolone Acetonide in Eye Injury Trauma, sponsored by Moorfields Eye Hospital NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-17.
Sponsored by Moorfields Eye Hospital NHS Foundation Trust · Phase 3, Interventional, and Treatment
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 trauma.There 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.
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.
23 studies on the registry are indexed under Eye Injuries; 2 are open to participants now.
Browse Eye Injuries studies →Moorfields Eye Hospital NHS Foundation Trust is the lead sponsor of 48 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
The patient will receive the standard care given to all patients that have received a vitrectomy following open globe trauma.
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
Also known as: kenalog
Improvement of visual acuity at 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)
Time frame: 6 months
Total visual acuity score at 6 months
Total EDTRS score in the study eye at the 6 months follow up appointment
Time frame: 6 months
Plan to share: Undecided
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Moorfields Eye Hospital NHS Foundation Trust