ClinicalTrials.gov
ClinicalTrials.gov Menu

Adjunctive Steroid Combination in Ocular Trauma (ASCOT) Study (ASCOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02873026
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Moorfields Eye Hospital NHS Foundation Trust

Brief 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.

Condition or disease Intervention/treatment Phase
Eye Injury Trauma Drug: Triamcinolone Acetonide Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.
Study Start Date : June 2014
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
No Intervention: Standard care
The patient will receive the standard care given to all patients that have received a vitrectomy following open globe trauma.
Experimental: 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.
Drug: Triamcinolone Acetonide
Following the repair of the open globe eye trauma, the use of Triamcinolone Acetonide will be investigated
Other Name: kenalog




Primary Outcome Measures :
  1. Improvement of visual acuity at 6 months [ Time Frame: 6 months ]
    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)


Secondary Outcome Measures :
  1. Total visual acuity score at 6 months [ Time Frame: 6 months ]
    Total EDTRS score in the study eye at the 6 months follow up appointment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873026


Contacts
Contact: Elizabeth Robertson, Phd 0207 5662285 elizabeth.robertson@moorfields.nhs.uk

Locations
United Kingdom
Moorfields Eye Hospital Recruiting
London, United Kingdom
Principal Investigator: David G Charteris, MD         
Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust
Investigators
Principal Investigator: David Charteris, MD Moorfields Eye Hosptial

Responsible Party: Moorfields Eye Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02873026     History of Changes
Other Study ID Numbers: CHAD1031
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Wounds and Injuries
Craniocerebral Trauma
Trauma, Nervous System
Eye Injuries
Facial Injuries
Nervous System Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action