Adjunctive Steroid Combination in Ocular Trauma (ASCOT) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2021-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Effectiveness of Drop-free Small Incision Cataract Surgery

NCT05248139

Cataract Ocular Inflammation Ocular Hypertension +1 more

UNKNOWN NA

Ketorolac Plus Tobramycin/Dexamethasone Versus Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery

NCT01103401

Cataract

COMPLETED NA

Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOC

NCT06681688

Cataract

RECRUITING PHASE1/PHASE2

Safety/Efficacy of Antibiotic Steroid Combination in Treatment of Blepharitis and/or Keratitis and/or Conjunctivitis

NCT00732446

Blepharitis Conjunctivitis Keratitis

COMPLETED PHASE3

Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty

NCT00485108

Primary Open Angle Glaucoma Pseudoexfoliation Glaucoma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Trauma is an important cause of visual impairment and blindness worldwide and a leading cause of blindness in young adult males.Globally it has been estimated that 1.6 million people are blind as a result of ocular trauma with 2.3 million suffering bilateral low vision. Ocular trauma is the commonest cause of unilateral blindness in the world today with up to 19 million with unilateral blindness or low vision. It is estimated that almost one million people in the United States live with trauma-related visual impairment. Ocular trauma has extensive socio-economic costs - patients with open globe injuries lose a mean of 70 days of work. In the United States work related eye injuries cost over $300 million per year (www.prevent blindness.org) this equates to an annual cost to the UK economy (for which no comparable data exists) of £37.5 million.

In the UK it is estimated that 5000 patients per year sustain eye injuries serious enough to require hospital admission and of these 250 will be permanently blinded in the injured eye. Recent European studies document incidences of 2.4 and 3.2 per 100000 per year for open-globe injuries which suggests an annual incidence for the UK of between 1500 and 2000.

Ocular injuries which result in visual loss invariably affect the posterior segment of the eye and prevention of visual loss involves posterior segment (vitreoretinal) surgery. It is clear from recent published data that although vitreoretinal surgical techniques have improved, outcomes remain unsatisfactory and that development of the intraocular scarring response proliferative vitreoretinopathy (PVR) is the leading cause of this.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Eye Injury Trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard care

The patient will receive the standard care given to all patients that have received a vitrectomy following open globe trauma.

Group Type NO_INTERVENTION

No interventions assigned to this group

Triamcinolone acetonide

Triamcinolone Acetonide 4mg/0.1ml intravitreal cavity and 40mg/1ml subtenons to be injected at the time of the vitrectomy. Patients will then receive standard care following operation.

Group Type EXPERIMENTAL

Triamcinolone Acetonide

Intervention Type DRUG

Following the repair of the open globe eye trauma, the use of Triamcinolone Acetonide will be investigated

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Triamcinolone Acetonide

Following the repair of the open globe eye trauma, the use of Triamcinolone Acetonide will be investigated

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

kenalog

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No