Efficacy and Safety of Prostaglandin Analogue and Carbonic Anhydrase Inhibitor for the Treatment of Pediatric Glaucoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Percentage of Eyes With Response
研究概览
简要总结
Objectives:
The study will assess the ocular hypotensive effect of latanoprost and dorzolamide in a selected sample of patients affected by primary Pediatric Glaucoma (PG), refractory to surgical procedures. Safety will be assessed, too.In the first version of the protocol 96 eyes were forecasted to complete the enrolment. The protocol was then amended and now to complete the study 68 eyes should be included. This number of eyes could be achieved by recruiting from 34 to 68 patients due to not in all patients both eyes should be eligible for the study.
详细描述
Study design:
Single arm, prospective, experimental study. Due to ethical reasons and in order to adhere as much as possible to current clinical practice, the presence of a control arm is not planned. Due to the non-comparative nature of the study, no blinding of treatment is planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of either sexes, aged 0-12 years
- •Diagnosis of mono- or bilateral primary congenital glaucoma
- •IOP greater than or equal to 22 mmHg and lower than 27 mmHg
- •Only one previous ocular hypotensive surgical procedure for treatment of glaucoma among the following: goniotomy, trabeculotomy, trabeculotomy with adjunct of mitomycin C) (only for medical treatment at least one month before)
- •Parent informed consent to data processing (at registration)
- •Parent informed consent before any study procedure
排除标准
- •Secondary glaucoma (Sturge-Weber syndrome, type I neurofibromatosis, retinoblastoma, steroid-induced glaucoma, etc.)
- •Presence of concomitant abnormalities of the anterior segment of the eye (cataract, iridocorneal dysgenesia, congenital uveal ectropion uvea, etc.)
- •Previous treatment with the study drugs
- •Presence of concomitant systemic diseases (asthma, hypertension, cardiac disease, renal failure, etc.) that needs treatment with drugs, that could influence IOP (steroids, beta-blockers, angiotensin-converting-enzyme inhibitor -inhibitors diuretics, etc.)
- •Abnormalities of the cornea that could influence IOP readings (marked cornea edema)
研究组 & 干预措施
Latanoprost, Dorzolamide
According to intraocular (IOP) assessment, the eye will receive Latanoprost, Dorzolamide or both.
干预措施: Latanoprost, Dorzolamide (Drug)
结局指标
主要结局
Percentage of Eyes With Response
时间窗: 3 years
defined as those eyes in which the decrease of intraocular pressure (IOP) of at least 20% with respect to baseline assessment will be achieved and maintained during the 3-year period of study duration
次要结局
- Time to Treatment Failure (TTF)(3 years)
- Number of Eyes With an Adverse Event (AE)(3 years)
研究者
Luciano Quaranta MD
Associate Professor in Ophthalmology
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia