Condition category
Eye Diseases
Date applied
05/09/2014
Date assigned
05/09/2014
Last edited
04/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
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 (eye injuries) with 2.3 million suffering bilateral low vision (i.e., affecting both eyes). Eye trauma is the most common cause of one-sided blindness in the world today with up to 19 million with one-sided blindness or low vision. It is estimated that almost one million people in the United States live with trauma-related visual loss. Eye trauma has a burden on society and cost implications– patients with eye injuries lose a mean of 70 days of work. In the United States work-related eye injuries cost over $300 million per year. The study aims to see if an adjunctive triamcinolone acetonide, given at the time of surgery, can improve the outcome of surgery for open globe eye trauma.

Who can participate?
Adults aged over 18 with an open globe eye injury undergoing vitrectomy surgery.

What does the study involve?
Participants will be randomly divided into two equal groups. The study group will receive standard care and the addition of the steroid medication, and the control group will receive standard care alone. Following surgery, there will be the usual examinations and participants will be followed up for 6 months after surgery.

What are the possible benefits and risks of participating?
The risk is no higher than the risk of standard medical care. Triamcinolone acetonide has been used off label in clinical practice for many years by experienced specialists. It has been seen as very safe. The most common important side effect seen so far is elevated pressure in the eye (intraocular pressure).

Where is the study run from?
Moorfields Eye Hospital (UK)

When is study starting and how long is it expected to run for?
October 2014 to August 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Elizabeth Robertson
elizabeth.robertson@moorfields.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elizabeth Robertson

ORCID ID

Contact details

Moorfields Eye Hospital NHS Foundation Trust
162 City Road
London
EC1V 2PD
United Kingdom
+44 (0)20 7253 3411
elizabeth.robertson@moorfields.nhs.uk

Additional identifiers

EudraCT number

2014-002193-37

ClinicalTrials.gov number

Protocol/serial number

HTA 12/35/64

Study information

Scientific title

A phase III 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; the Adjunctive Steroid Combination in Ocular Trauma (ASCOT) trial

Acronym

ASCOT

Study hypothesis

The study aims to test the hypothesis that adjunctive triamcinolone acetonide, given at the time of surgery, can improve the outcome of vitreoretinal surgery for open-globe ocular trauma.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/123564
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0009/166509/PRO-12-35-64.pdf

Ethics approval

London - Central Research Ethics Committee, 05/09/2014, ref: 14/LO/1428

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Ophthalmology; Subtopic: Eye (all Subtopics); Disease: Ophthalmology

Intervention

The study will involve 300 participants recruited at vitroretinal surgery centres at 20 sites across England and Scotland. Participation will be followed 6 months following surgery.

Treatment arm: the following medications are only administered to participants allocated to the treatment arm of the study:
1. 4 mg/0.1 ml triamcinolone acetonide administered into the vitreous cavity by the operating surgeon at the end of the procedure
2. 40 mg/1 ml of triamcinolone acetonide administered into the subtenons space at the end of the procedure (where subtenons anaesthesia is used for postoperative analgesia, surgeons will be requested to administer the local anaesthetic mid-procedure i.e. not concurrently)

Intervention type

Drug

Phase

Not Applicable

Drug names

Triamcinolone acetonide

Primary outcome measures

Primary outcome measure as of 01/06/2016:
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).

Original primary outcome measures:
1. Corrected visual acuity score (ETDRS letter score) at 6 months after initial study surgery
2. Proportion of patients with an improvement from baseline to 6 months of at least 10 on the corrected visual acuity (ETDRS letter score)

Secondary outcome measures

Secondary outcome measures as of 01/06/2016:
1. Total EDTRS score in the study eye at the 6 months follow up appointment
2. The proportion of patients in whom retinal detachment with PVR occurs at any timepoint within 6 months of the study vitrectomy
3. The proportion of patients in whom stable complete retinal reattachment (without internal tamponade present) is achieved at 6 months post study vitrectomy
4. The proportion of patients in whom stable macular retinal reattachment (without internal tamponade present) is achieved at 6 months post study vitrectomy
5. The proportion of patients in whom a tractional retinal detachment occurs at any timepoint within 6 months of the study vitrectomy
6. The number of operations to achieve stable retinal reattachment (either complete or macula) at 6 months after the study vitrectomy
7. The proportion of patients who suffer hypotony (<6mm Hg) at any timepoint within 6 months of the study vitrectomy
8. The proportion of patients who suffer raised intraocular pressure (>25mm Hg)
at any timepoint within 6 months of the study vitrectomy
9. The proportion of patients who develop macula pucker by 3 and 6 months and/or require macular pucker surgery at any timepoint within 6 months of the study vitrectomy
9. Quality of Life is measured using:
9.1. Client Service Receipt Inventory (CSRI) at baseline (1 page), 3 and 6 months (2 pages). At baseline, participants will be asked to recall service use in the last 4 weeks and at 3 and 6 months participants will be asked to recall their service use for the previous 3 months
9.2. EQ-5D-5 at baseline, 3 and 6 month
9.3. VFQ-25 at baseline, 3 and 6 month

Original secondary outcome measures:
1. The proportion of patients in whom retinal detachment with PVR occurs at any timepoint within 6 months of the study vitrectomy
2. The proportion of patients in whom stable complete retinal reattachment (without internal tamponade present) is achieved at 6 months post study vitrectomy
3. The proportion of patients in whom stable macular retinal reattachment (without internal tamponade present) is achieved at 6 months post study vitrectomy
4. The proportion of patients in whom a tractional retinal detachment occurs at any timepoint within 6 months of the study vitrectomy
5. The number of operations to achieve stable retinal reattachment (either complete or macula) at 6 months after the study vitrectomy
6. The proportion of patients who suffer hypotony (<6 mmHg) at any timepoint within 6 months of the study vitrectomy
7. The proportion of patients who suffer raised intraocular pressure (>25 mmHg) at any timepoint within 6 months of the study vitrectomy
8. The proportion of patients who develop macula pucker by 3 and 6 months and/or require macular pucker surgery at any timepoint within 6 months of the study vitrectomy
9. Quality of Life:
9.1. Client Service Receipt Inventory (CSRI). Primary and secondary health and social care service use will be recorded using a brief CSRI created for the study. The CSRI will be recorded at baseline (1 page), 3 and 6 months (2 pages). At baseline, participants will be asked to recall service use in the last 4 weeks and at 3 and 6 months participants will be asked to recall their service use for the previous 3 months.
9.2. EQ-5D-5. The EQ-5D is a generic, preference-based, health-related quality of life (HRQoL) measure. It consists of two parts: a five-item questionnaire and a visual analogue scale (EQ-VAS). The EQ-5D-5L questionnaire is scored between -0.59 and 1, with 1 meaning full HRQoL. Currently, no scoring algorithm exists to convert EQ-5D-5L responses into an index score, therefore we will use an interim scoring algorithm that maps responses onto the EQ-5D-3L. The EQ-VAS is a thermometer scored between 0-100, with respondents asked to mark their current HRQoL level.
9.3. VFQ-25. The VFQ25 measures vision-related QoL. Items are converted into a score between 0-100, where 100 represents full capability, and then the subscales are averaged to produce the composite score.

Overall trial start date

01/10/2014

Overall trial end date

30/08/2017

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 300; UK Sample Size: 300

Participant 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)

Recruitment start date

01/10/2014

Recruitment end date

30/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom

Sponsor information

Organisation

Moorfields Eye Hospital NHS Foundation Trust (UK)

Sponsor details

162 City Road
London
EC1V 2PD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The protocol and statistical analysis plan have both been submitted for publication and are currently under review.

Intention to publish date

31/12/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27449500
2016 statistical analysis plan in: http://www.ncbi.nlm.nih.gov/pubmed/27484082

Publication citations

Additional files

Editorial Notes

04/08/2016: Publication reference added. 28/07/2016: Publication reference added.