Endophthalmitis Postoperative Clinical Trial
Official title:
Intracameral Levofloxacin (0.5%) Versus Intracameral Cefuroxime (1mg/0.1ml) Effect on Corneal Endothelial Cell Count and Morphology in Uneventful Phacoemulsification
Endophthalmitis is a clinical diagnosis made when intraocular inflammation involving both posterior and anterior chamber; is attributable to bacterial or fungal infection. It is a serious intraocular inflammatory disorder which can be spread via endogenous or exogenous access into the eye by infecting organism. Exogenous spread usually happens post intraocular surgery or procedure (i.e. cataract, vitrectomy, glaucoma filtration surgery) while endogenous spread is associated with hematogenous spread. The occurrence of endophthalmitis accounts for serious post-operative complication which can lead to severe vision loss and even blindness. There are several studies conducted to ascertain the efficiency of intracameral antibiotic as post-operative endophthalmitis prophylaxis. However, there is limited study in human using intracameral levofloxacin to evaluate its effect.This study is designed to compare between intracameral levofloxacin and intracameral cefuroxime in terms of corneal endothelial cell count and its morphology and central corneal thickness in uncomplicated phacoemulsification surgery
This is a prospective, double - blinded randomized clinical trial conducted in University
Kebangsaan Malaysia Medical Centre (UKMMC). All patients from Ophthalmology Clinic in UKM
Medical Centre from December 2018 till June 2021 will be involved in this study. Patients who
fulfill the inclusion criteria will be included in this study.
Preoperative assessment includes proper history taking and ocular examinations.Ocular
examination includes baseline visual acuity, slit lamp examinations to ascertain the cataract
grading, anterior chamber reactions preoperatively, intraocular pressure measurement via
applanation tonometry and fundus examinations using 78D condensing lens. Cornea endothelial
examinations will be done by using non-contact TOPCON Specular Microscopy model SP-1P.
On the day of surgery, patients will be informed about the two different antibiotics
available that will be used at the end of cataract surgery. A written informed consent will
be obtained from the patient.
Patients will be randomized before entering the operating theatre. Sealed envelopes total of
4 will be prepared by the researcher; 2 of which will be labelled as A and another 2
envelopes will be labelled as B. The researcher will randomly pick 1 envelope and allocate to
patient's file. The staff nurse in charge will then open the envelope, label A or B will then
be pasted on the patient's file (rear part) for documentation.
Cataract surgery will be performed byusing Centurion®Vision System, Alcon, Texas, United
Stated of America (USA) phacoemulsification machine. 0.3 ml of levofloxacin 0.5% ophthalmic
solution (Cravit®, Santen) will be syringed out and at the conclusion of cataract surgery,
the solution of 0.1ml which has 0.5 mg levofloxacin will be injected via intracameral into
the anterior chamber through the side port wound using a tuberculin syringe in a 27 gauge
cannula.
On the other hand, at the beginning part of surgery, cefuroxime will be diluted by the
researcher. In order to reduce dilution error and contamination, dilution will be done
strictly according to a standardised protocol that was obtained from Malaysian Clinical
Practice Guideline. The vial contains 750 mg of cefuroxime powder is diluted with 7.5 ml of
Balanced Salt Solution (BSS). 1 ml of the solution will be withdrawn and added with 9 ml of
BSS. Then, 0.1 ml of solution which is equivalent to 1 mg of cefuroxime will be aspirated and
kept a side. Then the antibiotic of 0.1 ml will be given as intracameral to patient using a
tuberculin syringe in a 27 gauge cannula at side port wound at the end of surgery. The side
port wound will then be sealed by stromal hydration and checked for water tightness.
This will be followed by instillation of topical guttae ciprofloxacin 0.3% (Ciloxan, Alcon)
and guttae dexamethasone 0.1% (Maxidex, Alcon) and eye shield will be applied before leaving
the operating theatre.
Patient will be reviewed again after 2 hours post operatively at the slit lamp and eye drops
guttae ciprofloxacin 0.3% and guttae dexamethasone 0.1% will be instilled every 2 hours (5
minutes apart from one eye drop to another) for the first one week post-surgery. Upon
discharge, patient will be reviewed again in eye clinic after 1 week and during this visit,
these eye drops will then be tapered to 4 hourly for two weeks then six hourly for two weeks
until next review. After one month the eye drops will be discontinued.
Patients will then be reviewed after one week, one month and three months post operation.
During each visit, patient will be examined under slit lamp to look for anterior chamber
reaction and to measure intraocular pressure. They will undergo specular microscopy
examination to assess cornea endothelial cell count and morphology and central cornea
thickness.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04212429 -
The Clinical Safety of Levofloxacin 1.5% vs Topical Moxifloxacin 0.5%
|
Phase 1/Phase 2 | |
| Completed |
NCT03634852 -
A Two Chemoprophylaxis Approaches After Phacoemulsification Surgery
|
Phase 4 |