Uddevalla Skövde Transscleral Micropulse Study: Efficacy and Safety of Micro Pulse Transscleral Laser Treatment (MP-TLT) in Glaucoma Patients Performed in Topical Lidocaine Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Relative IOP change (percent) for POAG and PXFG eyes separately
研究概览
简要总结
Micro pulse transscleral laser treatment (MP-TLT) is a relatively new method to reduce the intraocular pressure (IOP) in glaucoma. New recommendations regarding the treatment protocol has recently been developed and was published 2022.
The overall objective is to evaluate the efficacy and safety of the proposed treatment method in an independent study. In addition, the outcome of MP-TLT in patients with pseudoexfoliation glaucoma, which is relatively common in the Nordic countries, and primary open angle glaucoma will be studied separately.
The IOP change over the course of one year will be monitored, as well as success rate and survival. Further, patient-reported discomfort from the treatment and the occurrence of any adverse events or complications will be studied.
详细描述
Forty patients scheduled for MP-TLT by their ophthalmologist will be recruited. One eye per patient is included, based on randomization, even if both are treated. MP-TLT will be performed according to the current recommendations.
Baseline IOP will be calculated as the mean of three separate measurements taken on different days preoperatively. IOP will then be measured 1 week, 1 month, 3 months, 6 months and 12 months after MP-TLT.
The central corneal thickness (CCT), the central retinal thickness (CRT), anterior chamber flare and the visual field (HFA 24-2 faster) will also be measured preoperatively and during follow up.
In accordance with the World Glaucoma Association guidelines, no adjustment for multiple comparisons is planned in this study.
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
- •Diagnosis of primary open angle glaucoma (POAG) or pseudo exfoliative glaucoma (PXFG)
- •Age ≥ 18 years
- •The patient is expected to be able to adequately undergo and cooperate in the treatment and follow-up as described in the study protocol.
- •The patient is judged to have good compliance with already prescribed pharmacological glaucoma treatment.
排除标准
- •Allergy or hypersensitivity to tetracaine or lidocaine
- •Prior transscleral laser or cryo treatment.
- •Prior eye surgery (including intravitreal injection) or pressure-lowering laser treatment (SLT/ALT/MDLT) during the last 2 months.
- •Planned or expected eye surgery (eg., cataract surgery or intravitreal injection) in the coming year.
- •History of macular edema.
- •History of corneal edema.
- •History of uveitis during the past year.
- •Existing thinning in the sclera of a greater extent than 30 degrees (one "clock-hour") of the circumference.
结局指标
主要结局
Relative IOP change (percent) for POAG and PXFG eyes separately
时间窗: 6 months
Relative IOP change (percentage relative to baseline) for the eyes with a diagnosis of primary open angle glaucoma, or pseudo exfoliative glaucoma, respectively. "Last observation carried forward" will be used in cases with treatment escalation or reduction during follow up. Patients with peroral glaucoma treatment at baseline are not included in this analysis.
Relative IOP change (percent)
时间窗: 6 months
Relative IOP (intraocular pressure) change (percentage relative to baseline) for the entire study population. "Last observation carried forward" will be used in cases with treatment escalation or reduction during follow up. Patients with peroral glaucoma treatment at baseline are not included in this analysis.
Perioperative pain on a visual analogue scale (VAS)
时间窗: Immediately after surgery
The patient will report pain during MP-TLT treatment on a VAS immediately after surgery. A 10 cm horizontal line without markings will be presented. One end of the line represents "no pain" and the other "worst imaginable pain". The patient marks the position on the scale that corresponds to the level of perceived pain. The number of millimeters from the "no pain" end is the result. Higher is worse. If there was a need for supplementary anesthesia, the grading applies to the experience before supplementation.
次要结局
- Survival(12 months)
- Change of flare in the anterior chamber postoperatively(1 month)
- Change in visual field index (VFI) during follow-up(12 months)
- Change in central retinal thickness (CRT) postoperatively(3 months)
- Relative change (percent) of the IOP 1 week, 1 month, 3 months and 12 months after MP-TLT.(12 months)
- Patient reported discomfort on an arbitrary scale(1 month)
- Adverse events(12 months)
- Postoperative pain on a VAS 1 hour, 5 hours, and 24 hours postoperatively(1 hour, 5 hours, and 24 hours postoperatively)
- Change in central corneal thickness (CCT) postoperatively(1 month)
- Success proportion after 12 months(12 months)