Prospective, Randomized Comparison of Corticosteroid Dosing Regimens Following Endothelial Keratoplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Intraocular Pressure
研究概览
简要总结
Graft rejection has traditionally been one of the leading causes of cornea transplant failure. To help prevent rejection, corticosteroid eye drops are used for an extended period after transplant surgery. The purpose of this study is to compare the efficacy and side effects of different corticosteroid dosing regimens after endothelial keratoplasty (cornea transplant) surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •At least 18 years of age
- •Male or female patient who had endothelial keratoplasty procedure within the past 1 to 7 weeks
- •Patient is able and willing to administer eye drops
- •Patient is able to comprehend and has signed the Informed Consent form.
- •Patient is likely to complete the one-year course of the study
排除标准
- •A history of a previous rejection episode in the study eye
- •A patient exhibiting intraocular inflammation
- •A patient with a known sensitivity to any of the ingredients in the study medications
- •A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
- •A patient with abnormal eyelid function.
- •A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis.
- •Presence of any ocular disease that would interfere with the evaluation of the study treatment. However, patients with a history of cystoid macular edema, age-related macular degeneration, controlled glaucoma, corneal neovascularization, and other non-interfering comorbidities may be enrolled.
- •A patient with a history of non-compliance with using prescribed medication.
- •A patient who is concurrently involved in or participated in another randomized clinical trial within 30 days prior to enrollment in this study.
- •Patients who are pregnant or planning to become pregnant within the duration of the study
研究组 & 干预措施
Loteprednol
Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months
干预措施: loteprednol etabonate (Drug)
Prednisolone acetate
Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months
干预措施: prednisolone acetate 1% (Drug)
结局指标
主要结局
Intraocular Pressure
时间窗: from 1 to 12 months after transplant
Number of eyes in which the absolute intraocular pressure equaled or exceeded 24 mm Hg OR in which there was a relative increase of at least 10 mm Hg over the baseline preoperative reading.
次要结局
- Immunologic Graft Rejection Episode(within first year after cornea transplantation)