The Effects of Topical Beta Blocker and Prostaglandin on Interval Intraocular Pressure in Intravitreal Injection - a Randomised Controlled Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- IOP effect of prophylactic IOP lowering eye drops over multiple time points
研究概览
简要总结
This is a prospective study of IOP in Intravitreal injections to evaluate:
- IOP effect of intravitreal injection
- IOP response to prophylactic beta blocker or Prostaglandin vs control (Hypromellose) over multiple time periods
- IOP response in correlation to number of injections, IOL, type of anti VEGF, co morbidities
详细描述
Study design: A prospective study Sample size: 60 patients (180 readings) Recruitment: Patients will be recruited at the intravitreal injection clinic in Grantham Hospital.
Randomization:
Group 1: control (hypromellose), then Timolol, then Travatan Group 2: Timolol, then Travatan, Hypromellose Group 3: Travatan, then Hypromellose, Timolol
There are three groups of different treatments. Patients recruited will undergone all three groups of treatments. During the first injection visit, patients will be randomized (by envelope method upon recruitment) to start with one of the three groups by envelope method. Treatment given to each group according to randomization in the first visit, then rotated to second and third group at two subsequent injections accordingly.
Injection doctors masked to treatments given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
Patients are not exposed to the eye drop bottle (taped) and the doctors measuring pressure and performing the intravitreal injections are not shown the eye drops given
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AMD patients requiring multiple intravitreal injections (Eylea or Lucentis), not necessarily 3 month loading.
- •Chinese patients with ability to read Chinese ICF
排除标准
- •Known glaucoma
- •Corneal disease e.g. corneal scarring or opacity preventing fundal view
- •On steroid or anti glaucoma eye drops
- •Prior vitrectomy or glaucoma surgery
- •Recent intraocular surgery i.e. cataracts surgery
- •Pseudophakic with anterior chamber IOL
- •History of ocular inflammatory disease e.g. uveitis
- •Previous laser iridotomy
- •Recent intravitreal injection of steroid
- •Inability for regular follow-up
研究组 & 干预措施
Group 3
Travatan, then Hypromellose, Timolol
干预措施: Timolol (Drug)
Group 1
control (hypromellose), then Timolol, then Travatan
干预措施: Timolol (Drug)
Group 1
control (hypromellose), then Timolol, then Travatan
干预措施: Travatan (Drug)
Group 1
control (hypromellose), then Timolol, then Travatan
干预措施: Hypromellose (Drug)
Group 2
Timolol, then Travatan, Hypromellose
干预措施: Timolol (Drug)
Group 2
Timolol, then Travatan, Hypromellose
干预措施: Travatan (Drug)
Group 2
Timolol, then Travatan, Hypromellose
干预措施: Hypromellose (Drug)
Group 3
Travatan, then Hypromellose, Timolol
干预措施: Travatan (Drug)
Group 3
Travatan, then Hypromellose, Timolol
干预措施: Hypromellose (Drug)
结局指标
主要结局
IOP effect of prophylactic IOP lowering eye drops over multiple time points
时间窗: From baseline to 30 minutes after injection
IOP in mmHg
次要结局
- IOP effect of intravitreal injection(From baseline to 30 minutes after injection)
- IOP response to types of anti VEGF, IOL, type of anti VEGF and co-morbidities(From baseline to 30 minutes after injection)
- Inflammation to types of anti VEGF(1 week post injection)