MicroPulse Transscleral Laser Therapy: A Prospective UK Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 主要终点
- Change in medication use following treatment
研究概览
简要总结
This Prospective Interventional Study will assess the efficacy of MPTLT in the UK.
详细描述
We are establishing a National Study of MPTLT procedures, co-ordinating with all UK treatment centres to capture prospectively, details of all MPTLT surgical procedure and outcomes. This will create a National UK Registry of MPTLT, allowing us to comply with NICE requirements while adding to the quality of evidence available to support this minimally invasive therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 with glaucoma or ocular hypertension deemed clinically suitable for MPTLT treatment by their treating ophthalmologist; this includes but is not limited to (a) need for lower IOP, (b) need for fewer medications based on side effects, poor compliance, adverse effect on lifestyle or (c) evidence of disease progression based on function or structure
- •Risk of invasive surgical procedure deemed too high by patient or surgeon
- •Aged 18 years or older
- •The ability to understand and comply with the trial consent process and procedures
- •Willingness to be part of a national registry
- •Ability to attend for follow-up
- •Ability to give informed consent, or consent given by relative or carer
排除标准
- •Clinical situations where in the opinion of the investigator, the ocular surface may be compromised by probe contact, including severe ocular surface inflammation
- •Inability to give informed consent
- •Unwillingness to have clinical data stored in a secure electronic format
- •Inability to comply with the study or follow-up procedures
结局指标
主要结局
Change in medication use following treatment
时间窗: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
Change in mean number of glaucoma medications before and after treatment
Change in intra-ocular pressure (IOP) following treatment
时间窗: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
Change in mean IOP before and after treatment, measured in mmHg using Goldmann Applanation Tonometry
次要结局
- Change in visual field (VF) following treatment(At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36)
- Change in Retinal Nerve Fibre Layer (RNFL) following treatment(At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36)