Quantitative Comparison of the Efficacy of Subtenon 20-mg Triamcinolone Injection With 0.1% Dexamethasone Eye Drop in Controlling Intraocular Inflammation After Phacoemulsification
试验速览
- 阶段
- 4 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Anterior chamber reaction
研究概览
简要总结
Phacoemulsification is a quick method with less complication for cataract surgery. Due to the use of ultrasonic energy, it produced more post-operative inflammation than other methods. Many routes of steroid had been used to control post-operative inflammation. The investigators here compare the efficacy of single depot steroid subtenon injection (20-mg triamcinolone) with four-time-a-day steroid eye drop (0.1% dexamethasone) in controlling inflammation after uneventful phacoemulsification.
详细描述
Cataract is one of the most common causes of blindness in the world. Surgical removal of lens is the only treatment for cataract, which now shifts from extracapsular cataract extraction to phacoemulsification. Although phacoemulsification provides faster operating time and gives better optical result and rapid recovery to the patient, it causes more inflammation post-operatively compare with extracapsular cataract extraction. Corticosteroids eye drops are mainly use to control intraocular inflammation after the surgery.
Other routes of corticosteroids have been introduced to increase the intraocular level and to increase the patient's compliance. Subtenon triamcinolone injection is easy and safe. Antiinflammatory effect of single subtenon triamcinolone injection lasts about 4-6 weeks. This method has been used in combination with corticosteroid eye drop to control the inflammation after cataract surgery in uveitic patients. It shows potency in controlling of intraocular inflammation with lower rate of increasing the intraocular pressure. The investigators here quantitatively compare the efficacy of subtenon 20-mg triamcinolone injection with 0.1% dexamethasone eye drop in controlling intraocular inflammation after uneventful phacoemulsification.
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
- Single (Participant)
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 older than 18 years old
- •Uncomplicated cataract patient scheduled for phacoemulsification and posterior chamber intraocular lens implantation
- •No History of prior intraocular procedures or any eye diseases such as uveitis, glaucoma, diabetic retinopathy
- •No History of systemic autoimmune diseases
- •No History of allergy to corticosteroids or to any component of the study medications
- •No History of using corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), or immunomodulating agents within 3 months prior to surgery
排除标准
- •Complications occurred during cataract surgery such as ruptured posterior capsule, vitreous loss, or dropped nucleus
- •Pregnant and lactating women
研究组 & 干预措施
Dexamethasone
Dexamethasone 0.1%/Tobramycin 0.3% eye drop 4 times per day for 28 days
干预措施: Placebo (Drug)
Triamcinolone
Subtenon 20-mg Triamcinolone injection
干预措施: Subtenon 20-mg triamcinolone injection (Drug)
结局指标
主要结局
Anterior chamber reaction
时间窗: postoperative day 28
proportion of anterior chamber reaction grade 0 measured by anterior chamber inflammation score at postoperative day 28+/-5
次要结局
- rate of increased intraocular pressure over 21 mmHg(preoperative, postoperative day 1,7,14,28,90)
- Changes of anterior chamber reaction over time(preoperative, postoperative day1, 7, 14, 28, 90)