CTRI/2024/01/061897招募中3 期
Intraglandular platelet rich plasma injection in moderate to severe dry eye disease: A placebo-controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean change from baseline in total corneal staining
研究概览
简要总结
Patients with moderate to severe dry eye disease due to lack of lacrimal gland function will receive PRP injection fortnightly for one month and it will be compared with placebo injection.
Purpose of the study is to evaluate the efficacy of intraglandular PRP injection in dry eyes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Aged 18–70 years
- •Have OSDI scores ≥33 or Oxford staining grade ≥2
- •Have a best corrected visual acuity (BCVA) in both eyes of +0.7 logMAR 4.Diagnosis of DED in both eyes supported by the criteria mentioned below Defined by at least one eye meeting all the following criteria: o A symptom severity score of ≥22 for OSDI o An unanesthetized Schirmer Tear Test (STT) score of ≥1 mm and ≤5 mm per 5 minutes o Evidence of ocular surface staining (total fluorescein staining score of at least 3) [0-15 scale])
- •Have normal lid anatomy and no other ocular disease except refractive errors or cataract.
排除标准
- •Uncontrolled systemic diseases, active infection or chronic kidney disease, liver cirrhosis, advance cancer.
- •Pregnant or nursing women.
- •3.Have not recently used the following medications, interventions, surgery, Anticoagulants or anti-platelets,Topical undiluted blood products within 3 months, Punctal plug or contact lenses, Ocular surgery within 6 months.
- •4.Have no contraindication for blood donation, Positive HIV, hepatitis B or C, or syphilis, Anaemia.Hemoglobin less than 110 grams per Litre.
结局指标
主要结局
Mean change from baseline in total corneal staining
时间窗: week 4, week 12
次要结局
- Mean change from baseline in the score of dry eye questionnaires, change in Schirmer values & NIBUT, degree of burning or stinging sensation(week 4, week 12)
研究者
Dr Swati Singh
L V Prasad Eye Institute
研究点 (1)
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