Randomized Controlled Study on the Efficacy of Punctal Cautery in severe Dry Eye disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in dry eye symptoms assessed using validated questionnaires such as the Ocular Surface Disease Index (OSDI) score.
研究概览
简要总结
Dry eye syndrome (DES) is a prevalent ocular condition characterized by a disruption in tear film stability and ocular surface inflammation, leading to symptoms such as ocular discomfort, visual disturbances, and, in severe cases, corneal damage. Punctal cautery, a minimally invasive procedure involving the thermal occlusion of puncta, has been suggested as a potential therapeutic option for dry eye disease (DED). However, evidence on its efficacy and safety is limited, necessitating a randomized controlled trial to evaluate its utility in managing DES.
Primary outcomes are change in Schirmer value and dry eye symptoms (OSDI) at 3 months follow-up. Secondary outcomes are change in tear break-up time, corneal fluorescein and conjunctival Lissamine staining scores, tear meniscus height and bulbar redness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Aged 5–70 years
- •Have OSDI scores ≥33 or Oxford staining grade ≥2
- •Diagnosis of DED in both eyes supported by the criteria mentioned below a.A symptom severity score of ≥33 for OSDI b.An unanesthetized Schirmer Tear Test (STT) score of ≥1 mm and ≤5 mm per 5 minutes c.Evidence of ocular surface staining (total fluorescein staining score of at least 3) [0-15 scale])
- •Have normal lid anatomy and diagnosed with severe dry eye (ATDDE)
- •DED refractory to medical management.
排除标准
- •1.History of punctal occlusion or punctal dilation.
- •2.Active ocular infection or inflammation.
- •3.Use of punctal plugs within the past 3 months.
- •4.Pregnancy or lactation women.
- •5.Any systemic or ocular condition that may interfere with the study assessments or participant safety.
- •6.Punctal plug or contact lenses.
- •Have no contraindication for blood donation 8.Positive HIV, hepatitis B or C, or syphilis.
结局指标
主要结局
Change in dry eye symptoms assessed using validated questionnaires such as the Ocular Surface Disease Index (OSDI) score.
时间窗: 1 month, 3 months
次要结局
- Visual Acuity, Adverse events related to intervention(1 month and 3 months)
研究者
DrSwati Singh
L V Prasad Eye Institute