Adjunctive steroid combination in ocular trauma study

Not Applicable

Completed

• Conditions: Open-globe ocular trauma; Topic: Ophthalmology; Subtopic: Eye (all Subtopics); Eye Diseases; Disease: Ophthalmology

• Registration Number: ISRCTN30012492
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust (UK)

Brief Summary

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27449500 protocol 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37840322/ (added 16/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-05
• Study Completion: 2020-12-01
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

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 (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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measure as of 01/06/2016:<br>The proportion of patients with an improvement from baseline to 6 months of at least 10 on the corrected visual acuity in the study eye (total ETDRS letter score measured at 4 metres and 1 metre).<br><br>Original primary outcome measures:<br>1. Corrected visual acuity score (ETDRS letter score) at 6 months after initial study surgery<br>2. Proportion of patients with an improvement from baseline to 6 months of at least 10 on the corrected visual acuity (ETDRS letter score)