IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- To detect a 60% or greater decrease of developing ocular hypertension (>20 mmHg) in the group of patients who received a trial of prednisolone 1% gtts x 4 weeks, compared the group who did not receive a trial of topical prednisolone.
研究概览
简要总结
Intravitreal triamcinolone acetonide (IVTA) is a commonly employed treatment for various vitreoretinal disorders. However, approximately 23% to 50% of patients who receive IVTA develop ocular hypertension after the drug is injected into the eye. Similar to IVTA, topically administered corticosteroids eye drops result in ocular hypertension in approximately 33% of the population. It is unknown whether identifying patients who develop ocular hypertension from topical corticosteroids could be used to identify patients who are at risk for injectable IVTA. Therefore, the purpose of this study is to evaluate the efficacy of topical prednisolone 1% four times daily for one month as a screening test to reduce the incidence and severity of ocular hypertension after IVTA injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •Patients diagnosed with vitreoretinal disease for which IVTA has been chosen as treatment
排除标准
- •< 18 years old
- •Pregnancy
- •Breast feeding
- •hx of uveitis
- •hx of neovascularization of the iris or anterior chamber angle
- •hx of ocular herpes simplex keratitis
- •hx of glaucoma
- •Unable to provide informed consent
研究组 & 干预措施
1
Patients receive Prednisolone 1% 1gtt qid x 4 weeks. If the intraocular pressure (IOP) after the 4 weeks is > or equal to 21 mmHg, then IVTA will be withheld. If the IOP < 21mmHg, then patients will receive an injection of IVTA.
干预措施: Prednisolone 1% topical eye drops (Drug)
结局指标
主要结局
To detect a 60% or greater decrease of developing ocular hypertension (>20 mmHg) in the group of patients who received a trial of prednisolone 1% gtts x 4 weeks, compared the group who did not receive a trial of topical prednisolone.
时间窗: Monthly for 6 months
次要结局
- Visual Acuity(Monthly for 6 months)
- Incidence of other complications (cataract, retinal detachment, endophthalmitis)(Monthly for 6 months)