Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Relative IOP reduction for each SLT iteration
研究概览
简要总结
Glaucoma is a common eye disease that can lead to blindness. The only known way to reduce the rate of disease progression is by reducing the pressure in the eye (the intraocular pressure, IOP). Selective laser trabeculoplasty (SLT) is an ophthalmic laser intervention with the purpose of reducing the IOP.
SLT can be performed in different ways, with four of the treatment protocols being evaluated in the Optimal SLT (OSLT) trial.
SLT is a repeatable procedure, but scientific evidence is scarce regarding more than one repetition. In this trial, patients included in the OSLT trial will be invited to the extended trial (OSLT-R), for further follow-up and re-treatment with SLT, if needed.
详细描述
Subjects already included in the OSLT trial (NCT03798223) will be invited to the extended trial (OSLT-R) at the time of SLT re-treatment or when OSLT follow up is scheduled to terminate. Patients are re-treated as needed, according to the randomized group assignment performed in the OSLT inclusion process.
The OSLT-R trial is aiming to elucidate:
- If the SLT efficacy, in terms of relative IOP reduction (percent of baseline IOP), changes with additional SLT iterations.
- If the longevity of IOP reduction after SLT changes with additional SLT iterations.
- If repeated SLT is associated with a change in postoperative discomfort or adverse events.
All of the above will be analyzed within each of the four treatment groups (SLT protocols) in the trial. Further, analysis will also be conducted regarding differences between the treatment groups regarding the above.
Further, analysis will be performed regarding SLT efficacy depending of the total number of SLT:s an eye has received, including those performed before entering the OSLT and OSLT-R trials.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The treatment protocol is masked for the patient and for the nurses and optometrists conducting measurement of intraocular pressure during follow-up.
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
- •Included in the OSLT trial
- •Followed up without the need for other treatment escalation than repeat SLT
排除标准
- •Unable to participate in follow up due to health conditions, strength or physical location.
结局指标
主要结局
Relative IOP reduction for each SLT iteration
时间窗: 1-6 months after each SLT, as described above
Relative IOP reduction for each SLT iteration is calculated as the percentage IOP reduction from baseline (the mean of 3 pre-SLT measurements) to result IOP (the mean of the IOP at follow-up 1, 3 and 6 months after SLT).
次要结局
- Pain perioperatively: on a scale(Immediately after treatment)
- Pain postoperatively: on a scale(During the first month)
- Survival (for each SLT iteration)(From randomization to failure (IOP lowering intervention, except repeat SLT) or censoring (death, patients choice), assessed until the last of: 1. 3 years after randomization; 2. 31 Dec 2024 or; 3. Six months after the last SLT during that timespan.)
- Light sensitivity postoperatively: on a scale(During the first month)
- Survival (repeat SLT allowed)(From each SLT iteration to failure (IOP lowering intervention incl. repeat SLT) or censoring (death, patients choice), assessed until the last of: 1. 3 years after randomization; 2. 31 Dec 2024 or; 3. Six months after the last SLT during that timespan.)
- Achievement of 20% reduction in IOP(From randomization until the last of: 1. 3 years after randomization; 2. 31 Dec 2024 or; 3. Six months after the last SLT during that timespan.)
- Absolute IOP reduction for each SLT iteration(1-6 months after each SLT, as described above)
- Impairment of vision postoperatively: on a scale(During the first month)
- Redness postoperatively: on a scale(During the first month)
- Adverse events(From randomization until the last of: 1. 3 years after randomization; 2. 31 Dec 2024 or; 3. Six months after the last SLT during that timespan. However, generally adverse events are anticipated to emerge in the first post-operative days or weeks.)