Comparative evaluation of perioperative subconjunctival triamcinolone acetonide injection versus postoperative topical prednisolone for prevention of intra-ocular inflammation following phacoemulsification
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of subconjunctival triamcinolone acetonide suspension 0.5 ml at a concentration of 40mg/ml injection given during cataract surgery for reducing post-operative intra-ocular inflammation.
研究概览
简要总结
Cataract is the leading cause of blindness in India constituting to 66.21% .
Regardless of the etiology, surgery is the only treatment for cataracts that impair vision. Despite the developments in equipment and techniques, complications can still arise during and after surgery. Two of the most common complications post cataract surgery are anterior segment inflammation and cystoid macular edema
Post cataract surgery topical drops such as non-steroidal anti-inflammatory drugs (NSAIDs) and steroids have been the mainstay for prophylaxis and treatment of inflammation.In phacoemulsification, due to the small incision size, the amount of inflammation is pretty mild and a non-steroid such as ketorolac can handle it. Conventionally topical dexamethasone or prednisolone is given in the post-operative period to reduce the inflammation. The safety and efficacy of these drugs have been established in many studies.
Sub-conjunctival triamcinolone acetonide (SCTA) depot offers a therapeutic approach with a sustained anti-inflammatory effect. It can also reduce complications resulting from patient’s non-compliance and inexperience with the use of conventional eye drops. It is a moderate-strength corticosteroid with a relatively long duration of actionIts efficacy is clinically equivalent to conventional 1% prednisolone eye drop in reducing intra-ocular inflammation as measured by clinical method.
Intraocular injections of steroids during cataract surgery, also known as drop-less surgery, have become more popular as a technique that allows for less reliance on postoperative drops without sacrificing outcomes for visual acuity or inflammation control.In this procedure, steroid depot can be administered in sub-tenons, intravitreal, or in subconjunctival space.
Although drop-less cataract surgery has many benefits, only a few studies have examined the risk of steroid response,the effectiveness, dose, safety, and tolerability of a single perioperative SCTA injection in place of topical steroid eye drops, as a part of the drop-less postoperative care protocol, for prevention of intra-ocular inflammation post cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients eligible for cataract surgery under peribulbar anesthesia.
- •Patients with uneventful cataract surgery.
排除标准
- •Patients with uncontrolled diabetes mellitus, or glaucoma, patients with a prior history of uveitis, and patients on systemic anti-inflammatory treatment.
- •Patients with corneal diseases, infectious ocular lesions, and high myopes.
- •Patients with existing retinal abnormalities.
- •Patients with complicated cataract surgery and prior ocular surgery.
- •Patients with documented allergy to triamcinolone acetonide.
- •Patients not responding to SCTA injection given during surgery.
结局指标
主要结局
To evaluate the efficacy of subconjunctival triamcinolone acetonide suspension 0.5 ml at a concentration of 40mg/ml injection given during cataract surgery for reducing post-operative intra-ocular inflammation.
时间窗: Day 1, 7, 30, 90
次要结局
- To evaluate the efficacy of postoperative 1 % prednisolone eye drops in preventing intraocular inflammation following phacoemulsification.(Day 1, 7, 30, 90)
- To compare the visual acuity, contrast sensitivity and steroid response, in cases of subconjunctival triamcinolone with the topical prednisolone eye drops in phacoemulsification.
研究者
Ankita Singh
school of medical sciences and research