Preferred treatment for removal of corneal rust
| ISRCTN | ISRCTN22641495 | 
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22641495 | 
| Secondary identifying numbers | N0185146360 | 
- Submission date
 - 30/09/2005
 - Registration date
 - 30/09/2005
 - Last edited
 - 11/04/2014
 
- Recruitment status
 - No longer recruiting
 - Overall study status
 - Completed
 - Condition category
 - Eye Diseases
 
            
            Prospectively registered
        
    
                    
                        
    
        
            
            Protocol
        
    
                    
                        
    
        
            
            Statistical analysis plan
        
    
                    
                        
    
        
            
            Results
        
    
                    
                        
    
        
            
            Individual participant data
        
    
                    
                        
    
        
            
            Record updated in last year
        
    
                    
                    Plain English summary of protocol
Not provided at time of registration
Contact information
                                            Ms Jean Middleton
Scientific
                                        Scientific
                                                Accident & Emergency OPD Department
Royal Eye Infirmary
Dale Road
Mutley
Plymouth
PL4 6PL
United Kingdom
                                                
Study information
| Study design | Randomised controlled trial | 
|---|---|
| Primary study design | Interventional | 
| Secondary study design | Randomised controlled trial | 
| Study setting(s) | Not specified | 
| Study type | Not Specified | 
| Scientific title | |
| Study objectives | To identify what is best practice for removal of corneal rust, ensuring that patient care is not compromised. | 
| Ethics approval(s) | Not provided at time of registration | 
| Health condition(s) or problem(s) studied | Eye Diseases: Corneal damage | 
| Intervention | Patients will be randomly allocated 2 or 5 days using sealed envelopes.   The following will be undertaken: 1.Case History, 2.Visual Acuity, 3. Examination: Slit lamp bio microscopy 4. Check whether patient fits criteria, 5. ask patient to participate, give patient information sheet, obtain consent. 6. Nurse practitioner opens envelope to identify 2 or 5 days. 7. Size and depth of foreign body will be measured and documented. 8. Other signs, symptoms documented eg inflammation. 9. pain score 1-10 analogue scale 10. procedure of removal 11. measurement of rust remaining 12 treatment given i.e medication, whether padded 13, follow up appointment according to random allocation 14 repeat visits to follow above procedure 15 telephone call to be made if follow up appointment not attended.  | 
| Intervention type | Other | 
| Primary outcome measure | Aims & Objectives: To identify what is the best practice for removal of cornea rust, ensuring that patient care is not compromised. To compare differences in discomfort felt by the patient and healing process of the cornea when visits are at 2 or 5 day intervals. Study endpoints: To compare ease and completion of removal of cornea rust. | 
| Secondary outcome measures | Not provided at time of registration | 
| Overall study start date | 27/02/2003 | 
| Completion date | 28/02/2004 | 
Eligibility
| Participant type(s) | Patient | 
|---|---|
| Age group | Not Specified | 
| Sex | Not Specified | 
| Target number of participants | Not provided at time of registration | 
| Key inclusion criteria | Not provided at time of registration | 
| Key exclusion criteria | Not provided at time of registration | 
| Date of first enrolment | 27/02/2003 | 
| Date of final enrolment | 28/02/2004 | 
Locations
Countries of recruitment
- England
 - United Kingdom
 
Study participating centre
                                            Accident & Emergency OPD Department
                                        
                                        
                                            
                                            Plymouth
PL4 6PL
United Kingdom
                                    PL4 6PL
United Kingdom
Sponsor information
                                            Department of Health
Government
                                        Government
                                                Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
                                                
| Phone | +44 (0)20 7307 2622 | 
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en | 
Funders
Funder type
Government
                                                Plymouth Hospitals NHS Trust (UK), Own Account
                                            
                                            No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No | 
| IPD sharing plan summary | Not provided at time of registration | 
| Publication and dissemination plan | Not provided at time of registration | 
| IPD sharing plan |