Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SILC201109v2
Study information
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
Acronym
SILC
Study hypothesis
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
Local medical research ethics committee, 23/03/2010
Study design
Single-centre prospective double-blind randomised controlled trial
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
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
Phase
Phase II/III
Drug names
Levofloxacin, cefuroxime
Primary outcome measures
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 trial start date
01/10/2010
Overall trial end date
01/10/2011
Reason abandoned
Objectives no longer viable
Eligibility
Participant 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.
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
30
Participant 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
Recruitment start date
01/10/2010
Recruitment end date
01/10/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Ophthalmology
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guys' and St Thomas' Hospital NHS Foundation Trust (UK)
Sponsor details
Joint Clinical Trials Office
3rd Floor
Conybeare House
Great Maze Pond
London
SE1 7EH
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Guys' and St Thomas' Hospital NHS Foundation Trust (UK) - Funded internally
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary