2024-520083-33-00招募中4 期
Selective laser trabeculoplasty versus eye drops for first line treatment of exfoliation ocular hypertension or glaucoma: a randomised clinical trial
HUS-Yhtymae1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2024年12月19日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Primary end point is acceleration of the treatment by adding eye drops.
研究概览
简要总结
The main objective of the trial is to show the equilance in efficacy of SLT laser treatment compared to medical therapy as a primary therapy in exfoliation glaucoma.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age of 50 –100 years
- •Possibility to attend 12 months of period
- •Exfoliation
- •Newly diagnosed exfoliation glaucoma by EGS (European glaucoma society) guidelines or ocular hypertensio TA 24 mmHg or more
- •Eye pressure less than 35 mmHg
排除标准
- •Advanced glaucoma
- •Serious other medical condition preventing participation in the trial
- •Participating in other clinical trial
- •Target IOP less than 15
- •Starting eye pressure 35 or more
- •Visual acuity 0.2 or worse
- •Angle closure
- •Unable to use eye drops
- •Significant cataract
- •Other active eye disease (active uveitis, clinical significant macular edema, wet AMD, proliferative diabetic retinopathy, intraocular tumor, intraocular injections, IOL luxation)
- •Previous intraocular operation excluding uncomplicated cataracta surgery 1 year ago or earlier
结局指标
主要结局
Primary end point is acceleration of the treatment by adding eye drops.
Primary end point is acceleration of the treatment by adding eye drops.
次要结局
- Secondary end points are eye dryness and eye pressure and long term end points are cumulative success of SLT-treatment and need for glaucoma surgery.
研究者
Department of Ophthalmology
Scientific
HUS-Yhtymae
研究点 (1)
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