Concentration of Ofloxacin Into the Aqueous Humour of Patients After Topical Instillation According to the Severity of Dry Eye Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- DED severity
研究概览
简要总结
After topical installation of one drop of 0.3% commercially available ofloxacin (Oxatrex®) four times at intervals of 15min in catarract patients with Dry Eye Disease, aqueous humour samples will be collected intraoperatively, one hour after the last installation. Concentration of ofloxacin in aqueous humour will be measured by HPLC-MS/MS.
详细描述
Patients will be categorized into three Groups, according to DED severity. Group I comprises of subjects without DED, Group II of patients are evaluated as non-severe DED, and Group III consists of patients suffering from severe DED.
The day before cataract surgery will be performed patient examination, during standard cataract preoperative evaluation. Briefly, symptom-based assessment will be delivered by scoring the Ocular Surface Disease Index (OSDI) questionnaire, and evaluation of ocular surface damage will be performed by corneal fluorescein staining using the Oxford scale.
Before surgery, patients will be assigned to receive one drop of commercially available topical ofloxacin solution 0.3% at monodoses without preservatives (Oxatrex, Zwitter Pharmaceuticals, Greece) four times at fifteen minutes intervals starting 2 hours before surgery. The eye drops will be applied in the middle of the inferior lower fornix. Patients who miss any of the 4 doses will be excluded from the study. Aqueous humor will be collected after 1 hour of the last administration, intraoperatively, at the beginning of cataract surgery.
A paracentesis track will be made with a 15ᵒ superblade, a 30G cannula, connected to a tuberculin syringe, will be inserted into the A/C and approximately 50 μL of aqueous humor will be withdrawn. AqH samples will be collected in an Eppendorf tube. All samples will kept frozen at -20ᵒC.
Ofloxacin concentrations will be determined by HPLC-MS/MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •cataract surgery
- •willing to participate
- •Exclusion criteria:
- •presence of exfoliation material within the anterior segment of the eye
- •pigment dispersion syndrome
- •anterior chamber angle < 20ᵒ
- •other ocular pathology than cataract
- •abnormal eyelid function
- •diabetes mellitus, renal or hepatic failure
- •chronic topical ocular treatment
- •systematic antibiotic treatment
- •allergy to fluoroquinolone antibiotics
- •contact lens use
排除标准
- 未提供
研究组 & 干预措施
Patients without Dry Eye Disease
Control Group
干预措施: Oxatrex (Drug)
Patients with Dry Eye Disease, except the severe Dry Eye Disease
non severe Dry Eye Disease
干预措施: Oxatrex (Drug)
Patients with severe Dry Eye Disease
severe Dry Eye Disease
干预措施: Oxatrex (Drug)
结局指标
主要结局
DED severity
时间窗: One day prior to cataract surgery, from 09:00am to 12:00pm
DED severity will be determined during preoperative cataract evaluation.
Concentration of ofloxacin in the aqueous humour
时间窗: Beginning of the cataract surgery, from 08:30am to 12:30pm
After topical instillation of ofloxacin eye drops, aqueous humor samples will be collected intraoperatively and ofloxacin concentration will be determined by HPLC-MS/MS.
次要结局
- Corneal staining(One day prior to cataract surgery, from 09:00am to 12:00pm)
- Ocular Surface Disease Index (OSDI)(One day prior to cataract surgery, from 09:00am to 12:00pm)
研究者
Constantinos D. Georgakopoulos, MD, PhD
Associate Professor in Ophthalmology
University Hospital of Patras