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 个研究点目标入组 300 人开始时间: 2014年9月5日最近更新: 2023年10月30日

适应症

试验速览

•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)

发起方

Moorfields Eye Hospital NHS Foundation Trust (UK)