Treatment of Blepharitis With Povidone-Iodine 1% : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Blepharitis signs on slit-lamp examination
研究概览
简要总结
One hundred blepharitis patients will be recruited. Each patient will treat one eye once daily with 1% PVI for 30 days by scrubbing the eyelid margin with the solution. The fellow eye will serve as the control and be given the standard treatment (commercial eye wipes). Before treatment initiation, various ocular surface variables will be assessed, such as dry eye grading, subjective discomfort scales, ocular surface questionnaire, and other clinical signs. After 30 days, an identical evaluation will be performed.
详细描述
Blepharitis is a chronic and very common inflammation of the eyelid margin affecting patients of all ages. This condition can be categorized anatomically (anterior- skin and eyelashes, posterior- meibomian glands), and pathophysiologically (staphylococcal, seborrheic, parasitic [Demodex mites], and meibomian gland dysfunction [MGD]). Combined forms of the disease are not uncommon. Signs and symptoms include itching, redness, flaking, and crusting of the lids, along with ocular surface disturbances such as irritation, dryness, tearing, and corneal damage.
Since no definitive cure is available, treatment recommendations for blepharitis focus on management. They may include eyelid hygiene using warm compresses and scrubbing, topical corticosteroids, topical and oral antibiotics, and dietary adjustments.
Povidone-iodine (PVI) is a widely used antimicrobial agent. Utilization of PVI is prevalent in disinfection of the eye and surrounding skin before intraocular procedures such as cataract surgeries and intravitreal injections. The antiseptic properties of PVI enable it to effectively reduce ocular surface and conjunctival colonization of various pathogens. Therefore, novel uses of ocular PVI seem promising, and some were already assessed in clinical studies.
The optimal concentration of PVI is also a matter of debate. High concentration solutions (5-10%) have greater potency, yet they increase corneal endothelial and epithelial toxicity. Although they may require repeated applications, low concentration solutions (0.1-1%) were proven to be safer and effective and are widely utilized in some countries. However, data regarding the option of treating blepharitis with PVI are lacking, as no comparative or controlled studies have been published to date.
In this study, the aim is to investigate the efficacy of lid scrubbing with PVI 1% in the treatment of anterior blepharitis
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
- Triple (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
- 否
入选标准
- •Age 18 or older.
- •Anterior or mixed (anterior + posterior) blepharitis.
- •Similar clinical condition of both eyes.
排除标准
- •Any ocular surface disease other than blepharitis.
- •Known allergy to iodine.
- •Eye surgery in the last 6 months.
- •Ocular trauma in the last 6 months.
- •Use of contact lenses in the last 6 months.
- •Pregnancy or lactation.
- •Daily use of makeup on lashes.
- •Any ocular or systemic medication that might affect the ocular microbiota (antibiotics, immunosuppressants, steroids).
研究组 & 干预措施
Study eyes
Once-daily eyelid hygiene with povidone-iodine 1%
干预措施: Povidone-Iodine 1 % Topical Solution (Drug)
Control eyes
Once-daily eyelid hygiene with available lid wipes
干预措施: Eyelid cleansing wipes (Drug)
结局指标
主要结局
Blepharitis signs on slit-lamp examination
时间窗: Day 30 (follow-up)
0-4 grading of each sign (normal, mild, moderate, severe, very severe): eyelid edema, eyelid erythema, scaling and crusting, meibomian glands clogging.
次要结局
- OSDI score(Day 30 (follow-up))
- Subjective eye complaints(Day 30 (follow-up))
- TBUT(Day 30 (follow-up))
- National Eye Institute/Industry (NEI) grading scale(Day 30 (follow-up))
- Schirmer's test(Day 30 (follow-up))
研究者
Elishai Assayag
Principal investigator
Shaare Zedek Medical Center