Comparison of the safety of two antibiotics - levofloxacin and cefuroxime - when they are used at the end of cataract surgery for the prevention of post-operative infection
| ISRCTN | ISRCTN31806847 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31806847 |
| Secondary identifying numbers | SILC201109v2 |
- Submission date
- 18/07/2009
- Registration date
- 29/07/2009
- Last edited
- 27/08/2014
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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
Mr David Spalton
Scientific
Scientific
Department of Ophthalmology
St Thomas Hospital
Westminster Bridge Rd
London
SE1 7EH
United Kingdom
Study information
| Study design | Single-centre prospective double-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Comparison of the Safety of Intracameral Levofloxacin to intracameral Cefuroxime for the prevention of endophthalmitis in cataract surgery (SILC): a single-centre prospective double-blind randomised controlled trial |
| Study acronym | SILC |
| Study objectives | There is no difference in the safety of intracameral levofloxacin and cefuroxime when used during cataract surgery for the prevention of endophthalmitis. On 14/06/2010 this record was updated to reflect changes in the protocol from SILC201109 version 1 to version 2. All updates can be found in the relevant field with the above update date. Please also note that the start and end dates of this trial have been changed from 01/09/2009 and 01/08/2010 to 01/10/2010 and 01/10/2011, respectively. The target number of participants was changed from 36 to 30. |
| Ethics approval(s) | Local medical research ethics committee, 23/03/2010 |
| Health condition(s) or problem(s) studied | Cataract surgery |
| Intervention | Participants requiring bilateral cataract surgery will be randomised firstly to receive cefuroxime or levofloxacin for their first eye surgery. Their fellow/second eye surgery will subsequently take place 5 weeks later. Follow-up for each eye following surgery will be one day after surgery, 3 weeks after surgery and 3 months after surgery for each eye. Following listing for cataract surgery and recuitment to the study there are a total of six out-patient appointments and two day surgery visits. Drug administration: Drug 1: Cefuroxime Dose: 1 mg in 0.1 mL Site of injection: Intracameral (i.e., into anterior chamber of eye) Frequency of administration: single dose at end of cataract surgery Drug 2: Levofloxacin Dose: 500 µg in 0.1 mL Site of injection: Intracameral (i.e., into anterior chamber of eye) Frequency of administration: single dose at end of cataract surgery Updated 27/08/2014: This study was abandoned in 2012 as levofloxacin is unlicensed for intraocular use and we never achieved MHRA/pharma consent despite 2 years of applications. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | Levofloxacin, cefuroxime |
| Primary outcome measure | Corneal endothelial cell count; a comparison will be made between pre-operative to post-operative results and between study groups (cefuroxime versus levofloxacin). |
| Secondary outcome measures | 1. Visual acuity 2. Intra-ocular inflammation (flare and cells) 3. Corneal thickness 4. Macular thickness These parameters will be compared from pre-operative to post-operative results and between study groups (cefuroxime versus levofloxacin). |
| Overall study start date | 01/10/2010 |
| Completion date | 01/10/2011 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Patients undergoing routine cataract surgery attending the ophthalmology outpatient clinic at St Thomas' Hospital 2. Aged 20-100 years 3. Male or female (of non-childbearing potential) 4. Clinically normal corneal and retinal examination 5. Past ocular history - no history of long-term ocular condition, long-term use of ocular medications or ocular surgery 6. Ability to comply with investigation and follow-up schedule 7. Patients must give informed written consent in order to participate in the study. Non-English speakers will be offered an interpreter. All consents will be witnessed. |
| Key exclusion criteria | 1. Unilateral cataract, very dense (brunescent or white) cataracts 2. Significant difference in corneal thickness, endothelial cell count/morphology or macular thickness of greater than 20% at baseline between the two eyes 3. Past ocular history in either eye of: 3.1. Pre-existing ocular conditions (glaucoma, retinal disease, uveitis, corneal disease) 3.2. Previous ocular surgery 3.3. Surgical complications in either eye 4. Diabetes requiring treatment 5. Medications: use of long-term topical eye drops with the exclusion of lubricant drops; use of tamsulosin (known to cause intra-operative floppy iris syndrome) 6. Allergies to fluoroquinolones, cephalosporins 7. Patients unable to give informed consent or are unable to understand the requirements of the trial |
| Date of first enrolment | 01/10/2010 |
| Date of final enrolment | 01/10/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Ophthalmology
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Guys' and St Thomas' Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Joint Clinical Trials Office
3rd Floor
Conybeare House
Great Maze Pond
London
SE1 7EH
England
United Kingdom
| Website | http://www.guysandstthomas.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Government
Guys' and St Thomas' Hospital NHS Foundation Trust (UK) - Funded internally
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 |
