Intracameral Levofloxacin (0.5%) Versus Intracameral Cefuroxime (1mg/0.1ml) Effect on Corneal Endothelial Cell Count and Morphology in Uneventful Phacoemulsification
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Comparison of change in endothelial cell morphology in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with senile cataract and age 50 - 80 years
排除标准
- •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.
研究组 & 干预措施
A-Levofloxacin
0.1 ml/0.5mg of levofloxacin 0.5% ophthalmic solution
干预措施: Levofloxacin Ophthalmic (Drug)
B-Intracameral Cefuroxime
0.1 ml/1mg of Cefuroxime
干预措施: Cefuroxime (Drug)
结局指标
主要结局
Comparison of change in endothelial cell morphology in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
时间窗: 3-month post-operation
Change in Endothelial cell morphology from Baseline by assessing the Polymegathism (CV) which is the variation in individual cell areas, and Pleomorphism which is the increased in variability of cell shape, at 3-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of change in Central cornea thickness in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
时间窗: 3-month post-operation
Change in Central cornea thickness (µm) from Baseline, measured at 3-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of Anterior chamber reaction in patients treated with intracameral levofloxacin ophthalmic solution with intracameral cefuroxime in an uneventful phacoemulsification.
时间窗: 3-month post-operation
Anterior chamber cell grading refers to presence of inflammatory reaction in the anterior chamber (the space in front of iris plane and cornea endothelium). It is graded by counting the number of cells that is present with slit beam of 1mm x 1mm with high intensity of light measured using the slit lamp at 3-month post-operation
Comparison of change in Endothelial cell count concentration in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
时间窗: 3-month post-operation
Change in Concentration of Endothelial cell count (cells/mm2) from Baseline, measured at 3-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of change in Endothelial cell morphology in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
时间窗: 1-week post-operation
Change in Endothelial cell morphology from Baseline by assessing the Polymegathism (CV) which is the variation in individual cell areas, and Pleomorphism which is the increased in variability of cell shape, at 1-week post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
次要结局
- Side effects(Post-operative period until study completion, an average of 2 years)
研究者
Wan Haslina Wan Abdul Halim
Consultant Ophthalmologist-Cornea And Anterior Segment
National University of Malaysia