Intense Pulsed Light Therapy in the Treatment of Refractory Meibomian Gland Dysfunction
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Tear film break up time (TBUT)
研究概览
简要总结
to evaluate the effect of intense pulsed light on resistant patients with Meibomian gland dysfunction
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age of at least 20 years.
- •The diagnosis of obstructive MGD based on ocular symptoms, plugged gland orifices, vascularity and irregularity of lid margins, and reduced meibum expression (meibum grade of .1, where grade 0 = clear meibum easily expressed, grade 1 = cloudy meibum expressed with mild pressure, grade 2 = cloudy meibum expressed with more than moderate pressure, and grade 3 = meibum could not be expressed even with strong pressure).
- •failure of at least 3 types of conventional MGD therapy to improve symptoms or objective findings for at least 1 year before study treatment
排除标准
- •the presence of active skin lesions, skin cancer, or other specific skin pathology.
- •active ocular infection or ocular inflammatory disease.
结局指标
主要结局
Tear film break up time (TBUT)
时间窗: 6 months
After instillation of fluorescein in the conjunctival sac with fluorescein sodium strips (Jingming New TechnologicalDevelopment Co Ltd, Tianjin, China), the subject was asked to blink several times. Then, the tear film was observed under the slitlamp, using a cobalt blue filter to increase the visual contrast. For each eye, TBUT was evaluated three consecutive times, and the average of these three measurements was calculated and taken for the analysis.TBUT, a cut-off value of 5 sec was used to distinguish between moderate/severe TBUT (#5 sec) and mild/normal TBUT (.5 sec)
schirmmer staining
时间窗: 6 months
doctor places a piece of filter paper inside the lower eyelid of both eyes and the person closes their eyes. After 5 minutes, the doctor removes the filter paper. The doctor then assesses how far the tears have travelled on the paper. Result under 10 mm is considered to be an abnormally low level of tear production
Standard Patient Evaluation of Eye Dryness (SPEED)questionnaire
时间窗: 6 months
the self evaluated Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire (Tear Science, Morrisville, VC). This validated questionnaire asked the subject to grade the frequency and severity of four symptoms categories: (1) dryness, grittiness or scratchiness; (2) soreness or irritation; (3) burning or watering; and (4) eye fatigue. For each of these symptom categories, the subject subscored the frequency using a 4-point scale (0 never, 1 sometimes, 2 often, 3 constant), and subscored the severity using a 5-point scale (0 none, 1 tolerable, 2 uncomfortable, 3 bothersome, 4 intolerable). The SPEED score was calculated as the sum of these eight subscores. A SPEED score of 10 is widely accepted as indicating severe DED symptoms, and a cut-off value around six is often used to distinguish between asymptomatic/mild and moderate/severe symptoms.
次要结局
未报告次要终点
研究者
magda torky
catract and refractie surgery specilaist
Dar Al Shifa Hospital