drugset / Trial / NCT02873026
Adjunctive Steroid Combination in Ocular Trauma (ASCOT) Study
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2014-10
- Primary completion
- 2020-03-31
- Completion
- 2021-01-31
Publications
- Ezeofor V', Anthony BF, Bryning L, Casswell EJ, Cro S, Cornelius VR, Bunce C, Robertson E, Kelly J, Murphy C, Banerjee PJ, Charteris DG, Edwards RT. Economic evaluation of an adjunctive intraocular and peri-ocular steroid vitreoretinal surgery for open globe trauma: Cost-effectiveness of the ASCOT randomised controlled trial. PLoS One. 2024 Dec 16;19(12):e0311158. doi: 10.1371/journal.pone.0311158. eCollection 2024.
- Casswell EJ, Cro S, Cornelius VR, Banerjee PJ, Zvobgo TM, Tudor Edwards R, Ezeofor V, Anthony B, Shahid SM, Bunce C, Kelly J, Murphy C, Robertson E, Charteris D; ASCOT Investigator Study Group. Randomised controlled trial of adjunctive triamcinolone acetonide in eyes undergoing vitreoretinal surgery following open globe trauma: The ASCOT study. Br J Ophthalmol. 2024 Feb 21;108(3):440-448. doi: 10.1136/bjo-2022-322787.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Triamcinolone Acetonide | Other / unclassified | 4 mg | Intravitreal |
| Subject | Triamcinolone Acetonide | Other / unclassified | 40 mg | Intravitreal |
Indications
No indication recorded.