A phase III 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; the Adjunctive Steroid Combination in Ocular Trauma (ASCOT) trial

Moorfields Eye Hospital NHS Foundation Trust (UK)0 sites300 target enrollmentSeptember 5, 2014

Overview

Registry

who.int

Start Date

September 5, 2014

End Date

December 1, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Moorfields Eye Hospital NHS Foundation Trust (UK)

•1\. Children (age less than 18 years old at time of enrollment)
•2\. Pre\-existing uncontrolled uveitis (this does not include patients whose uveitis is secondary to their injury or retinal detachment)
•3\. Definitive diagnosis of previous steroid\-induced glaucoma (this does not include patients in whom a query of previous steroid\-induced raised IOP has been postulated)
•4\. Pregnant or breastfeeding females. Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; true abstinence) from the time consent is signed until 6 weeks after completion of the trial. Females of childbearing potential must have a negative urinary pregnancy test within 7 days prior to being registered for trial treatment (subjects are considered not of childbearing potential if they are permanently sterile \[i.e. they have undergone a hysterectomy, bilateral tubal occlusion, or bilateral salpingectomy or they are postmenopausal]).
•5\. Allergy or previous known adverse reaction to triamcinolone acetonide
•6\. Inability to attend regular follow up.
•7\. Unable to give written informed consent.
•8\. Current or planned systemic corticosteroid use of a dose above physiological levels (e.g. \>10 mg prednisolone)