A Prospective Study on the Effect of Pre-cataract Surgical Ocular Hygiene Regime on Microbial Load, Tear Osmolarity, Dry Eye, and Inflammatory Markers Between Two Ocular Hygiene Regimen Groups
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Microbial load
研究概览
简要总结
This study assesses the impact of two differing ocular hygiene regimens prior to cataract surgery. The first regimen includes an omega-3 supplement and the second without, and both include an at-home lid wipe and cleansing eye drops. These regimens will be assessed on microbial load, inflammation, tear osmolarity, and dry eye metrics. Patients will be randomized to either the omega-3 group + 3-part hygiene regimen, or the group with only the 3-part hygiene regimen. Data will be collected for inflammation through a test (InflammaDry) that measures an inflammatory marker, dry eye metrics via an imaging tool called Oculus 5M and the Canadian Dry Eye Assessment (CDEA) questionnaire, tear osmolarity through Tear Labs device, and area of growth for conjunctiva microbial load by swabbing the conjunctiva of the eye. Dry eye metrics (CDEA and Oculus 5M) will be collected during the patient's baseline appointment, 2-5 days prior to surgery, and post-operative month 1. Microbial load swabs will be collected at baseline, 2-5 days prior to surgery, and date of the surgery. An ocular assessment will also be completed at baseline, one week post-operation, and one month post-operation. All metrics will be compared to the fellow eye. The usage of omega-3 will be compared to the regimen without omega-3.
详细描述
Prospective interventional study assessing the impact of two ocular hygiene regimens, with and without Omega-3, on microbial load, inflammation, tear osmolarity, and dry eye metrics and disease for patients soon to undergo cataract surgery. Study recruitment will occur at Uptown Eye between Sept-Nov 2023, with a target of 68 patients enrolled in the study. Patients will be consecutively randomized to group 1 (without omega 3 group) or group 2 (with omega 3 group). The intervention includes Zocular in clinic at baseline, Thealoz Duo eyedrops twice daily until surgery, and the cleansing wipes twice daily until surgery. The omega 3 group will take the supplement from baseline until one month post-operative.
Data will be collected for inflammation through a InflammaDry Matrix metallopeptidase 9 (MMP-9) test, dry eye through Oculus 5M (measures non-invasive break-up time (NIBUT), lipid layer, bulbar redness, tear meniscus height) and Canadian Dry Eye Assessment (CDEA), TearLab for osmolarity, and conjunctival swabs for microbial load. Dry eye metrics (CDEA and Oculus 5M) will be collected during the patient's baseline Cataract Dry Eye Clinic (CDEC) appointment, 2-5 days prior to surgery, and post-operative month 1. Microbial load will be collected at baseline, 2-5 days prior to surgery, and date of the surgery. Tear osmolarity and inflammation markers will be collected at baseline, 2-5 days prior to surgery, and post-operative month. An ocular assessment will also be completed at baseline, one week post-operation, and post-operative month. All metrics will be compared to the fellow eye.
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
- Single (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
- 否
入选标准
- •Patients 18 or older who underwent cataract surgical ocular hygiene treatment regimen prior to cataract surgery.
- •Patients of all severity of dry eye will be included.
排除标准
- •Patients with any other ocular comorbidities (glaucoma, iritis, traumatic eye injury, known systemic autoimmune diseases, immune disorders, anti-inflammatory medications, blood disorders (eg. altered white counts), prior surgery, prior traumatic eye injury, previous dry eye interventions such as ocular plugs, radiofrequency, and IPL).
- •Patients who have any complications arise during the cataract surgery.
- •Patients with altered mental state and cannot provide informed consent.
研究组 & 干预措施
Omega-3
Participants in this arm will take oral omega-3 supplement for 4 weeks pre-operatively and 4 weeks post-operatively. They will also receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home.
干预措施: Omega-3 (Dietary Supplement)
Omega-3
Participants in this arm will take oral omega-3 supplement for 4 weeks pre-operatively and 4 weeks post-operatively. They will also receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home.
干预措施: Trehalose (Drug)
Omega-3
Participants in this arm will take oral omega-3 supplement for 4 weeks pre-operatively and 4 weeks post-operatively. They will also receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home.
干预措施: Zocular Eyelid System Treatment (Drug)
Omega-3
Participants in this arm will take oral omega-3 supplement for 4 weeks pre-operatively and 4 weeks post-operatively. They will also receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home.
干预措施: Blephadex cleansing eyelid wipes (Other)
No Omega-3
Participants in this arm will not take oral omega-3 supplement. They will only receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home.
干预措施: Trehalose (Drug)
No Omega-3
Participants in this arm will not take oral omega-3 supplement. They will only receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home.
干预措施: Zocular Eyelid System Treatment (Drug)
No Omega-3
Participants in this arm will not take oral omega-3 supplement. They will only receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home.
干预措施: Blephadex cleansing eyelid wipes (Other)
结局指标
主要结局
Microbial load
时间窗: Baseline, 2-5 days prior to surgery, surgery day
Area of microbial growth from conjunctival swab reported as percentage of dish coverage, incubated for 48 hours
Tear osmolarity
时间窗: Baseline, 2-5 days prior to surgery, surgery day
Measure of salt concentration in tear reported as mOsm/L
MMP-9
时间窗: Baseline, 2-5 days prior to surgery, post-operative month 1
Level of MMP-9, an inflammatory marker reported as positive (level of MMP-9 \> 40ng/mL) or negative (level of MMP-9 \< 40ng/mL).
次要结局
- Lipid layer(Baseline, 2-5 days prior to surgery, post-operative month 1)
- Bulbar redness(Baseline, 2-5 days prior to surgery, post-operative month 1)
- Tear meniscus height(Baseline, 2-5 days prior to surgery, post-operative month 1)
- Canadian Dry Eye Assessment (CDEA) Questionnaire(Baseline, 2-5 days prior to surgery, post-operative month 1)
- Non-invasive break-up time (NIBUT)(Baseline, 2-5 days prior to surgery, post-operative month 1)