Safety and Effectiveness of Single-dose Subconjunctival Triamcinolone Compared to Topical Prednisolone Eye Drops in Manual Small Incision Cataract Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Mean post-operative intraocular pressure (IOP) in mmHg in each group
研究概览
简要总结
This is a randomized control trial comparing the effects of subconjunctival triamcinolone administration during surgery to topical prednisolone drops on the development of post-operative inflammation and macular edema in manual small incision cataract surgery.
详细描述
Eye drops given following cataract surgery for prevention of post-operative inflammation carry many disadvantages, such as cost and poor medication adherence. To eliminate these barriers, the emerging technique of single dose of subconjunctival triamcinolone delivered during surgery has been shown an effective and safe alternative. The goal of this study is to build on this evidence, utilizing subconjunctival triamcinolone in conjunction with a different surgical technique and population as what was previously studied. This is a randomized control trial comparing the effects of single-dose subconjunctival triamcinolone administration at the time of surgery to the standard 4-week taper of topical prednisolone drops following manual small incision cataract surgery in Guatemala. Patients will be evaluated at post-operative weeks 6 and 12 with the primary outcome variables of intraocular pressure and best corrected visual acuity. Data on presence and amount of corneal edema, anterior chamber inflammation, and development of macular edema will also be obtained.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of a visually significant cataract: nuclear sclerotic, posterior subcapsular and/or cortical
- •Best corrected visual acuity or 20/40 or worse
排除标准
- •Axial length < 20 or > 26 mm
- •Cataract which is traumatic, subluxated, or Morgagnian
- •Presence of ocular comorbidity: including corneal or retinal abnormalities (corneal opacities, macular degeneration, macular scars, epiretinal membrane, retinal detachment, retinal vascular occlusion), glaucoma, ocular hypertension, glaucoma suspect (cup-to-disc ratio of 0.7 or more, history of steroid response, history of uveitis, pseudoexfoliation
- •History of endophthalmitis or macular edema in the fellow eye
- •Personal history of diabetes mellitus or uncontrolled hypertension
- •Currently pregnant or lactating women
- •Current use of systemic steroids for asthma, rheumatoid arthritis or other illness or history of steroid use by any route in the prior 3 months.
- •Intraoperative complications including posterior capsular rupture, iris prolapse, zonular dialysis, retained nucleus, vitreous loss, iris trauma resulting in hemorrhage, Descemet dehiscence of more than 1 mm x 1 mm
研究组 & 干预措施
Single-dose steroid medication delivered during surgery
Subconjunctival injection of Triamcinolone acetonide.
干预措施: Intraoperative delivery of medication, Kenalog (Triamcinolone) (Drug)
Standard of care post-operative steroid drops
Prednisolone acetate ophthalmic solution, 4-week taper.
干预措施: Topical post-operative eyedrops, Prednisolone acetate (Drug)
结局指标
主要结局
Mean post-operative intraocular pressure (IOP) in mmHg in each group
时间窗: Pre-operative exam through post-operative month week 12
Comparison of mean IOP in mmHg obtained by applanation between control and intervention groups at all time points
Corrected distance visual acuity (CDVA)
时间窗: Pre-operative exam through post-operative week 12
Comparison of visual acuity following refraction quantified on a the logarithm of the minimum angle of resolution (LogMAR) scale with a range from -0.30 (Snellen equivalent 6/3) with exceptional vision to +3.00 which corresponds to poor vision or only able to discriminate hand motions.
次要结局
- Degree of inflammation using anterior chamber (AC) inflammation score(Pre-operative exam through post-operative week 12)
- Incidence of treatment-emergent macular edema(Post-operative month one through post-operative week 12)