Adjunctive Steroid Combination in Ocular Trauma (ASCOT) Study

• Status: Completed
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

1. Adult subjects (Aged 18 years or over at the time of enrolment)

2. Full thickness, open-globe ocular trauma undergoing vitrectomy

3. Ability to give written informed consent

4. Willingness to accept randomization and attend follow-up for 6 months.

Exclusion Criteria:

1. Children (Age less than 18 years old at time of enrollment)

2. Pre-existing uncontrolled uveitis - Patients with pre-existing uveitis are likely to be rare in the study population however they have a pre-disposition to a more aggressive form of proliferative vitreoretinopathy and will therefore be excluded. (This does not include patients whose uveitis is secondary to their injury or retinal detachment)

3. Definitive diagnosis of previous steroid induced glaucoma - these patients are at risk of steroid related pressure rise and will be excluded (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 their 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 child bearing 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. >10mg prednisolone)