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Trial registered on ANZCTR


Registration number
ACTRN12611000448943
Ethics application status
Approved
Date submitted
2/05/2011
Date registered
3/05/2011
Date last updated
3/12/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective, Randomized, Double-Blind Trial To Evaluate The Role of Topical Anaesthetics In Controlling Pain After Corneal Abrasion In The Emergency Department
Scientific title
A Prospective, Randomized, Double-Blind Trial To Evaluate The Role of Topical Anaesthetics In Controlling Pain After Corneal Abrasion In The Emergency Department
Secondary ID [1] 260088 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Corneal abrasions 265761 0
Condition category
Condition code
Eye 265913 265913 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Treatment Group will receive Tetracaine eye drops that are to be self administered (one drop) every 30 minutes into the injured eye while awake for the following 24 hours. The treatment group will receive a total of 1 ml Tetracaine Hydrochloride 1% (2x 0.5ml minims, approximately 30 drops).
Intervention code [1] 264503 0
Treatment: Drugs
Comparator / control treatment
The Control Group will receive Saline eye drops that are to be self administered (one drop) every 30 minutes into the injured eye while awake for the following 24 hours. The Control Group will receive one 5 ml bullet of Saline Solution (0.9% Saline).
Control group
Placebo

Outcomes
Primary outcome [1] 266672 0
The primary outcome of this study is to show that short term use of topical anaesthetics for corneal abrasions is safe and will not affect corneal healing.
Timepoint [1] 266672 0
The patients will be followed up at a 48 hour check where a senior medical physician will re examine the cornea under the slit lamp for evidence of adequate healing. Visual acuity will be tested on presentation at the Emergency Department and at the 48 hour follow up. Patients will be contacted by telephone at 1 week and 1 month where they will be asked additional questions to check how effective they thought he treatment drug was, if their vision has returned to normal, if they have experienced any adverse effects or if the suffered from any complications during or after the treatment.
Secondary outcome [1] 276168 0
The secondary outcome of this study is to show that short term use of topical anaesthetics will reduce pain for patients suffering from corneal abrasions.
Timepoint [1] 276168 0
The participants will complete a Pain Questionnaire for the 48 hours after leaving the Emergency Department. Pain level will be measured on a horizontal 10cm Visual Analog Scale. Participants will record their pain level every 30 minutes for the first 2 hours and then every 2 hours (while they are awake) for the next 48 hours.

Eligibility
Key inclusion criteria
Inclusion criteria includes any simple acute corneal abrasions from mechanical trauma, ultraviolet light, foreign body, or from removal of foreign body by the physician.

For patients to be eligible for this study they also need to have presented to the Emergency Department within 36 hours of their initial injury.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria. There are a number of reasons that subjects may be excluded from participating in this study.

If patients present to the Emergency Department more that 36 hours after their initial injury they will be excluded as the majority of corneal abrasion healing will already have occured.

If patients are under the age of 18.

If patients have had previous eye surgery or cataracts.

If patients wear contact lenses or if their injury was caused from contact lens wear.

If patients are unable to give informed consent.

If patients are suffering from infectious or chemical conjunctivitis.

If the patients eye contains a grossly contaminated foreign body.

If the patient is suffering from an ocular infection.

If the patient currently has herpes keratitis.

If the patient is allergic to Tetracaine or similar medication classes.

If the injury requires urgent ophthalmologic evaluation (e.g. penetrating eye injuries, large or complicated corneal abrasions or injuries causing a significant disruption of vision).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The medical care giver on initial visit will discuss the project with potential participants. Participants will be provided with an information sheet to read and if they are willing to participate they will be required to complete a full written consent form. If participants have any additional questions the Principle Investigator will answer these.

Participants will need to have a basic understanding of the English language to be able to participate in this study. They will be required to be able to provide informed consent, read the information sheet, fill out a questionnaire and answer basic questions over the telephone.

Numbered sealed envelopes will be placed into a box in the eye treatment area refrigerator. Patients will be assigned a study number in succession and will be given a similarly numbered envelope. Inside each envelope will be either the Tetracaine or Saline eye drops.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The decision on which treatment is placed into a given envelope will take place prior to the start of the study. The selection will occur through a random number generator using block randomisation, with random block sizes chosen from 6, 8 or 10 per block, and will only be known by the study researchers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3439 0
New Zealand
State/province [1] 3439 0
Southland

Funding & Sponsors
Funding source category [1] 264993 0
Self funded/Unfunded
Name [1] 264993 0
Neil Waldman MD
Address [1] 264993 0
Emergency Department
Southland Hospital
PO Box 828
Invercargill
9812
Southland
Country [1] 264993 0
New Zealand
Primary sponsor type
Hospital
Name
Southland Hospital
Address
Emergency Department
Southland Hospital
PO Box 828
Invercargill
9812
Southland
Country
New Zealand
Secondary sponsor category [1] 264083 0
None
Name [1] 264083 0
Address [1] 264083 0
Country [1] 264083 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266947 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 266947 0
c/- Ministry of Health
6 Hazeldean Rd
Christchurch
8024
Canterbury
Ethics committee country [1] 266947 0
New Zealand
Date submitted for ethics approval [1] 266947 0
20/04/2011
Approval date [1] 266947 0
Ethics approval number [1] 266947 0

Summary
Brief summary
The purpose of this study is to gain a greater understanding of the pain caused by eye injuries (corneal abrasions) and to determine if medication drops applied to the eye in the following 24 hours are a safe and effective form of pain relief.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32556 0
Address 32556 0
Country 32556 0
Phone 32556 0
Fax 32556 0
Email 32556 0
Contact person for public queries
Name 15803 0
Neil Waldman MD FACEM
Address 15803 0
Emergency Department
Southland Hospital
PO Box 828
Invercargill
9812
Southland
Country 15803 0
New Zealand
Phone 15803 0
+64 3 2181949 extension 6734
Fax 15803 0
Email 15803 0
neil.waldman@southerndhb.govt.nz
Contact person for scientific queries
Name 6731 0
Neil Waldman MD FACEM
Address 6731 0
Emergency Department
Southland Hospital
Po Box 828
Invercargill
9812
Southland
Country 6731 0
New Zealand
Phone 6731 0
+64 3 2181949 extension 6734
Fax 6731 0
Email 6731 0
neil.waldman@southerndhb.govt.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary