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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31806847
Enrollment
30
Registered
2009-07-29
Start date
2010-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract surgery Eye Diseases Other cataract

Interventions

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 p

Sponsors

Guys' and St Thomas' Hospital NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Corneal endothelial cell count; a comparison will be made between pre-operative to post-operative results and between study groups (cefuroxime versus levofloxacin).

Secondary

MeasureTime frame
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).

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026