Optimal Treatment Protocol for Selective Laser Trabeculoplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 8
- 主要终点
- Change in intraocular pressure (IOP)
研究概览
简要总结
A randomized controlled trial to evaluate which treatment protocol in selective laser trabeculoplasty that is most optimal in terms of efficacy and safety.
详细描述
A randomized controlled trial in which individuals scheduled for SLT are randomized to one of four treatment protocols, which represent the most common variants of the treatment in clinical use.
Treatment is performed either at 360 degrees or 180 degrees and with a laser energy level either 0,1 millijoules (mJ) below the microbubble formation limit ("standard" energy) or at a level that gives microbubbles at 50-75% of laser effects ("high" energy). This gives four treatment arms: 180/standard, 180/high, 360/standard and 360/high. Group allocation is masked for the patient and is coded in the records.
The results for short and long term treatment effects are compared between the groups, as well as the complication rate and postoperative discomfort.
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 conducting measures 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
- •diagnosis primary open-angle glaucoma, pseudo-exfoliative glaucoma or ocular hypertension.
- •intra-ocular pressure (IOP) at least 18 mmHg treatment day.
- •treatment is performed by an experienced laser surgeon.
- •SLT treatment and follow-up are expected to be possible to perform in an adequate way, considering anatomical factors, age and the general health of the patient.
排除标准
- •change of IOP-lowering medication during the last three months.
- •planned change of intra-ocular-pressure-lowering medication.
- •previous glaucoma surgery (other than SLT and ALT)
- •previous intra-ocular surgery during the last three months.
- •previous intra-ocular inflammatory disease during the last year.
- •planned intra-ocular surgery.
- •hyper-pigmented anterior chamber angle.
研究组 & 干预措施
180/high
SLT treatment in the lower half of the trabecular meshwork (180 degrees) consisting of 50+/-5 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects.
干预措施: SLT (Procedure)
360/high
SLT treatment in the full circumference of the trabecular meshwork (360 degrees) consisting of 100+/-10 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects.
干预措施: SLT (Procedure)
结局指标
主要结局
Change in intraocular pressure (IOP)
时间窗: Before SLT and thereafter regularly for 3 years
The IOP is measured with a Goldmann Applanation Tonometer (GAT) three times before SLT and then at regular intervals after the procedure. The reduction is registered and analyzed in absolute (mmHg) and relative (percent of the IOP before SLT) measures. Measurement of IOP is planned 1, 3, 6 and 12 months post SLT, and thereafter every six months for 3 years after SLT. The study is conducted in a regular clinical setting and the above mentioned times might be delayed. If target pressure is not achieved, measurements will be planned at shorter intervals, according to a specified algorithm, due to safety reasons.
Achievement of 20% reduction in IOP
时间窗: For 3 years
See Outcome 1. Analysis of differences between the study arms will also be conducted measuring the proportion of eyes achieving 20% reduction in IOP or more at different time points in each group.
Survival (no additional intervention)
时间窗: For 3 years
Kaplan-Meier survival analysis will be conducted, measuring the proportion of eyes that stay in the study groups but do not receive any further IOP-lowering intervention (medical, surgical or laser).
Change in intraocular pressure (IOP)
时间窗: Before SLT and thereafter regularly for 4 years
The IOP is measured with a Goldmann Applanation Tonometer (GAT) three times before SLT and then at regular intervals after the procedure. The reduction is registered and analyzed in absolute (mmHg) and relative (percent of the IOP before SLT) measures. Measurement of IOP is planned 1, 3, 6 and 12 months post SLT, and thereafter every six months for 4 years after SLT. The study is conducted in a regular clinical setting and the above mentioned times might be delayed. If target pressure is not achieved, measurements will be planned at shorter intervals, according to a specified algorithm, due to safety reasons.
Achievement of 20% reduction in IOP
时间窗: For 4 years
See Outcome 1. Analysis of differences between the study arms will also be conducted measuring the proportion of eyes achieving 20% reduction in IOP or more at different time points in each group.
Survival (no additional intervention)
时间窗: For 4 years
Kaplan-Meier survival analysis will be conducted, measuring the proportion of eyes that stay in the study groups but do not receive any further IOP-lowering intervention (medical, surgical or laser).
次要结局
- Pain postoperatively: on a scale(During the first month)
- Survival (SLT allowed)(For 3 years)
- Pain perioperatively: on a scale(Immediately after treatment)
- Redness postoperatively(During the first month)
- Light sensitivity postoperatively(During the first month)
- Impairment of vision postoperatively(During the first month)
- Flare (inflammation measurement of the anterior chamber)(Pre-operatively and then one day, one week and one month post-operatively.)
- Adverse events(3 years (although adverse events, if any, are anticipated to emerge in the first post-operative days or weeks).)
- Survival (SLT allowed)(For 4 years)
- Adverse events(6 months after SLT.)