A Randomized Controlled Trial of Treatment Efficacy in Ameliorating Demodex Spp. Infestation Among Cases Undergoing Cataract Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Mean Demodex spp. infestation index by intervention group
研究概览
简要总结
Demodex blepharitis is a prevalent cause of comorbid infection among individuals undergoing cataract surgery. Several complications may arise in the postsurgical period from Staphylococcus or Streptococcus co-infections, as Demodex is a vector for these pathogens. Hence, prophylactic treatments before cataract surgery may lead to a reduction in complication rates. Since Demodex infestation and cataract surgery are two prevalent coexisting conditions in the general population, this study aims to test the effect of four combined treatments to eradicate or improve the Demodex infestation index before surgery. The investigators are conducting a single-blinded randomized trial of four therapies in participants undergoing cataract surgery. All participants will or are receiving daily eyelid cleansing bid and topical 0.3% ciprofloxacin q4h for three days added to the allocated treatment arm. Our four intervention groups are: [1] Blephaclean eye scrubs; [2] 50% dilution baby shampoo; [3] tea tree oil shampoo; [4]: topical 0.3% ciprofloxacin alone. To assess treatment efficacy, the investigators will perform eyelash hair epilation pre and postoperatively. The primary outcome is a change in the mean Demodex spp. infestation index. Also, a change in the crude number of Demodex (egg, larvae, nymph, or adult-form) spp. in eyelashes after one-week of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators and outcomes assessors were blinded to the treatment allocation of each participant. Outcome assessors were anterior segment surgeons who evaluated cases prior to cataract surgery. There was no indication of group allocation in the electronic medical records (EMR), only the participation of each candidate in the study. Similarly, investigators were blinded to group allocation and only recorded data directly from EMR. Blinding was kept after data analysis.
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
- •Signed informed consent after explanation of the nature and possible consequences of the study.
- •Clinical diagnosis of cataracts staged with Lens Opacity Classification System III based on the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery guidelines.
- •No topical antibiotic ointment therapy or eyelid cleansing in the past six months.
- •No systemic antibiotic or antiparasite treatment in the past six months.
- •No ocular comorbidities (other than cataracts)
- •No systemic comorbidities.
排除标准
- •Withdrawal from the study.
- •Minimal changes based on the Lens Opacity Classification System III.
研究组 & 干预措施
Group 1: Topical 0.3% Ciprofloxacin [Cipro]
Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days.
干预措施: Ciprofloxacin Ophthalmic Ointment 0.3% (Drug)
Group 2: Cipro + 50% diluted baby shampoo
Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. Twice a day eyelid margin cleansing with 50% diluted baby shampoo for three days.
干预措施: Ciprofloxacin Ophthalmic Ointment 0.3% (Drug)
Group 2: Cipro + 50% diluted baby shampoo
Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. Twice a day eyelid margin cleansing with 50% diluted baby shampoo for three days.
干预措施: Baby shampoo (Other)
Group 3: Cipro + Blephaclean
Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. Twice a day eyelid margin cleansing with Blephaclean Sterile Eyelid Wipes (Thea Pharmaceuticals) for three days.
干预措施: Ciprofloxacin Ophthalmic Ointment 0.3% (Drug)
Group 3: Cipro + Blephaclean
Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. Twice a day eyelid margin cleansing with Blephaclean Sterile Eyelid Wipes (Thea Pharmaceuticals) for three days.
干预措施: Blephaclean (Other)
Group 4: Cipro + Tea tree oil.
Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. Twice a day eyelid margin cleansing with tea tree oil shampoo for three days.
干预措施: Tea Tree Oil Shampoo (Other)
Group 4: Cipro + Tea tree oil.
Ciprofloxacin Ophthalmic Ointment 0.3% every four hours for three days. Twice a day eyelid margin cleansing with tea tree oil shampoo for three days.
干预措施: Ciprofloxacin Ophthalmic Ointment 0.3% (Drug)
结局指标
主要结局
Mean Demodex spp. infestation index by intervention group
时间窗: One week.
Number of demodex (egg, larvae, nymph, adult-form) spp. per eyelash (taken from epilation).
Crude count of Demodex spp. adult-forms (mites) in eyelashes by intervention group
时间窗: One week.
Number of demodex (egg, larvae, nymph, adult-form) spp. in total (taken from epilation).
次要结局
- Endophthalmitis in the postoperative period.(One week.)
研究者
Andric C Perez-Ortiz, M.D., M.P.H.
Clinical Professor
Hospital de La Luz