Intracameral Levofloxacin (0.5%) vs Intracameral Cefuroxime

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University of Malaysia
• Collaborator: Santen Pharmaceutical Co., Ltd.
• Treatments: Cefuroxime; Cefuroxime axetil; Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

• All patients with senile cataract and age 50 - 80 years

Exclusion Criteria:

• Patients with cataract other than senile cataract (e.g. traumatic cataract)

• Patients with underlying cornea disease (e.g. cornea dystrophy)

• Patients with corneal endothelial disease/endothelial cell count less than 1000/sqmm².

• Patients with intraoperative complications such as posterior capsule rupture/ prolapsed iris/ zonulysis/ anterior vitreous loss.

• Cataract grading nucleosclerosis (NS) 2+ and below.