Adjunctive Steroid Combination in Ocular Trauma (ASCOT) Study
Research type
Research Study
Full 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; the adjunctive steroid combination in ocular trauma (ASCOT) trial
IRAS ID
156358
Contact name
David Charteris
Contact email
Sponsor organisation
Moorfields Eye Hospital NHS Foundation Trust
Eudract number
2014-002193-37
Research summary
Summary of Research
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. The retina is a thin layer which lines the inside of the eye. It is sensitive to light (like the film in a camera) and is necessary for vision. If a hole develops in the retina it can become detached. Patients whose eyes have suffered severe trauma have a high risk of developing scarring on the surface of the retina (PVR). This scar tissue pulls on the retina preventing the holes from being repaired by the standard technique used in other retinal detachment patients. If the retina remains detached the eye does not see, can lose its volume and appear unsightly.
Inflammation is the medical term used to describe the way in which the body reacts to injury. 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.
This is a randomised controlled clinical (RCT) trial to determine if the addition of such steroid medication (triamcinolone acetonide) at the time of surgery for penetrating eye trauma is effective in improving visual and surgical outcomes. An RCT is a research trial in which subjects are randomly assigned to 2 groups: one (the experimental group) receiving the treatment that is being tested, and the other (the comparison group) receiving no treatment or conventional treatment.
Participants will be divided in to two equal groups; the study group will receive standard care and the addition of the steroid medication, the control group will receive standard care alone. Follow up visits mirror routine clinical care and no additional invasive or time consuming tests are performed. The final assessment is performed at six months after the initial study surgery.
The trial is to be coordinated at Moorfields Eye Hospital and will involve 19 other specialist eye surgery units throughout the UK. Treatment success will be measured as the average level of improvement or loss in vision in the group receiving the study treatment.
We will also investigate factors including the number of operations required in each group, the proportion of people who develop PVR and perform an analysis to see how cost effective the study treatment is.
The study is expected to be completed in 4 years.Summary of Results
Despite advances in surgical techniques eye trauma remains a leading cause of blindness and visual impairment. The main cause of this is a scarring process within the eye – proliferative vitreoretinopathy (PVR). There is good evidence from laboratory work and small scale clinical studies that the addition of a steroid medication, triamcinolone acetonide (TA), given in and around the eye at the time of surgery for eye trauma can reduce the incidence of PVR scarring and improve the outcomes of surgery. The ASCOT study was a multicentre clinical trial designed to test the use of TA as an addition to surgery to improve outcomes in eyes with “open globe” penetrating injuries. 280 patients were recruited and randomised to standard surgery or surgery with the additional steroid (TA).
No benefit was found from the addition of the steroid medication. Secondary outcome measures suggested that TA may have had a negative effect on outcomes although this may have been due to more severe cases in the patient group which received the additional steroid (TA). The use of adjunctive triamcinolone acetonide in eye trauma cases undergoing surgery is therefore not recommended. Future studies with different additional medications and/or more targeted case selection are indicated to improve outcomes for eyes experiencing penetrating trauma.REC name
London - Central Research Ethics Committee
REC reference
14/LO/1428
Date of REC Opinion
5 Sep 2014
REC opinion
Favourable Opinion