Condition category
Eye Diseases
Date applied
18/07/2009
Date assigned
29/07/2009
Last edited
27/08/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr David Spalton

ORCID ID

Contact details

Department of Ophthalmology
St Thomas’ Hospital
Westminster Bridge Rd
London
SE1 7EH
United Kingdom

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

http://www.guysandstthomas.nhs.uk/

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

Publication citations

Additional files

Editorial Notes