Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline
研究概览
简要总结
The purpose of this study is to compare the change in visual acuity of patients with post surgical cystoid macular edema who will be treated with two different regimens.
详细描述
Compare the mean change in BCVA over 12 weeks of Prednisolone Acetate 1% q1h (every hour) WA (While Awake) + Ketorolac 0.5% qid (four times a day) versus Prednisolone Acetate qid + Ketorolac qid for post surgical cystoid macular edema.
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
- 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
- •Age more than or equal to 18 years
- •Diagnosis of PSCME in study eye confirmed by FA showing leakage from retinal vessels resulting in pooling of dye in the fovea and Spectralis SD-OCT showing intraretinal fluid in or around the fovea.
- •BCVA score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters).
- •In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from PSCME and not to any other reason.
排除标准
- •Any patient who has other retinal diseases known to cause macular edema (choroidal neovascularization, vein occlusion, diabetic macular edema in the study eye). Patients with nonexudative Age Related Macular Degeneration (ARMD) or non-proliferative diabetic retinopathy without macular edema can be included in the study.
- •Other reason for decreased visual acuity (such as amblyopia, foveal atrophy, optic atrophy).
- •Pre-existing diagnosis of glaucoma in the study eye
- •Inability to comply with study or follow up procedures
- •Pregnancy (Women of child bearing age will be asked to take a urine pregnancy test prior to enrolling in the study).
研究组 & 干预措施
PredA q1h WA + Kelac qid
Prednisolone acetate (PredA) 1% ophthalmic solution every 1 hr while awake (WA) and Ketorolac (Kelac) 0.5% ophthlmic solution four times a day (qid)
干预措施: PredA + Kelac (Drug)
PredA qid + Kelac qid
Prednisolone acetate (PredA) 1% ophthalmic solution four times a day (qid) and Ketorolac (Kelac) 0.5% ophthlmic solution four times a day (qid)
干预措施: PredA + Kelac (Drug)
结局指标
主要结局
Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline
时间窗: Baseline and Week 12
Mean change in best-corrected visual acuity (Letter Score) at Week 12 from Baseline. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision.
次要结局
- Mean Change in Intraocular Pressure at Week 12 From Baseline(Baseline and Week 12)
- Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48(Week 12 and Week 48)
- Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48(Week 12 and Week 48)
- Mean Change in Intraocular Pressure Between Week 12 and Week 24(Week 12 and Week 48)
- Mean Change in Central Subfield Thickness at Week 12 From Baseline(Baseline and Week 12)