Endophthalmitis Postoperative Clinical Trial
Official title:
The Clinical Safety of Topical Levofloxacin 1.5% vs Topical Moxifloxacin 0.5%
Endophthalmitis is defined as intraocular inflammatory disorder affecting the vitreous cavity
that can result from exogenous or endogenous spread of infecting organisms into the eye.
Patients presents with reduced or blurred vision, red eye, pain, and lid swelling.
Endophthalmitis can progress into panophthalmitis, corneal infiltration and perforation, and
finally phthisis bulbi. For exogenous endopthalmitis, the intraocular inflammation occurs due
to a breach of the ocular compartment. The infectious agent indirectly introduced into the
eye. This usually happens after intraocular surgery such as cataract surgery, vitrectomy,
glaucoma filtration surgery, intravitreal injections, and other causes include penetrating
ocular trauma or from adjacent periocular tissue. Several prophylactic measures have been
taken to reduce the incidence of post-operative endopthalmitis postcataract surgery, this
includes the use of pre-operative topical levofloxacin, intrameral cefuroxime, and providone
iodine as ocular surface preparation.The proposed study is to evaluate clinical safety of
Levofloxacin 1.5% and Moxifloxacin 0.5% on the anterior segment parameters.
This is a prospective, double - blinded randomized clinical trial conducted in University
Kebangsaan Malaysia Medical Centre (UKMMC) where there are two intervention arms. All
patients from Ophthalmology Clinic in UKM Medical Centre from September 2019 till December
2021 will be involved in this study. Patients who fulfill the inclusion criteria will be
included in this study. All eligible subjects will be asked to sign an informed consent.
The qualified patients will be randomized on a 1:1 ratio into each treatment arm. Qualified
eyes were further randomized into one of four subgroups, which specified the time between the
last drop of study medication and the time of aqueous and vitreous humor sample collection
(i.e., 1-, 2-, 4-, and 6-hour subgroups- about 32 patients per subgroup-: 16 Levofloxacin, 16
Moxifloxacin.
Patient will undergo clinical assessment at the outpatient Ophthalmology Clinic at UKMMC.
Initially, a non-contact assessment of the corneal surface will be done by the Keratograph 5.
The parameters recorded are non-invasive tear break up time (NITBUT), tear film properties
and redness analysis. The endothelial cell count will be analysed with a specular microscopy.
Subsequently, patient will be assessed by a blinded ophthalmologist for clinical evaluation
of corneal surface which includes tear break up time (TBUT), ocular surface abnormality and
Rose-bengal staining. During the first visit, each patient will be educated on proper
instillation of the eye drops to ensure the proper dose is administered. A prior observation
of self- instillation of the eye drop by the study staff is required.
For 3 days prior to the day of the elective vitrectomy surgery, subjects will instill exactly
one drop of study medication into their operative eye four times daily. On the day of surgery
(visit 2, day 4), patients will receive their final drop of study medication administered by
trained study personnel at the study site.
Post-vitrectomy, patients will be continued on the specified antibiotics for 4 hourly for 2
weeks. Then the antibiotic will taper down to 6 hourly (QID) daily for 1 week and antibiotics
will be discontinued after that. Corneal safety will be assessed at 1 week and 4 weeks post
operatively.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03634852 -
A Two Chemoprophylaxis Approaches After Phacoemulsification Surgery
|
Phase 4 | |
| Recruiting |
NCT04212078 -
Intracameral Levofloxacin (0.5%) vs Intracameral Cefuroxime
|
Phase 1/Phase 2 |