Direct Selective Laser Trabeculoplasty (DSLT) In Open Angle Glaucoma (POAG): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 9
- 主要终点
- The difference between the two treatment groups between the mean baseline IOP and the mean IOP after the treatment
研究概览
简要总结
Glaucoma is an eye disease that results in damage to the optic nerve that progresses over time. One of the main risk factors in glaucoma is an increase in intraocular pressure, caused by a build-up of fluid in the eye. Glaucoma can result in blindness if left untreated and as such it is extremely important to diagnose and treat the condition.
Selective Laser Trabeculoplasty (SLT) is a laser treatment that facilitates the outflow of fluid from inside the eye. This has the potential of reducing the intraocular pressure within the eye (the main way in which this disease is treated since there is no cure) and may assist in helping to control the progression of this disease.
SLT (standard treatment) is a technique routinely carried out by glaucoma specialists. It is conducted using a special type of lens (goniolens) that gently sits on the front surface of the eye. The procedure takes approximately 5 minutes in duration.
This new treatment, Direct Selective Laser Trabeculoplasty (DSLT) is performed directly, without there being any need to use a goniolens which sits on the eye, and it is a shorter and simpler technique to conduct when compared to the standard SLT technique.
The purpose of this study is to assess the hypothesis that the treatment by new automated device for DSLT is not worse in comparison with the standard SLT and determine that it is effective in reducing intraocular pressure.
详细描述
Glaucoma can result in blindness if left untreated and as such it is extremely important to diagnose and treat the condition.
Usually doctors treat the first symptoms of glaucoma or ocular hypertension by prescribing eye drops. Unfortunately, there can be side effects associated with the use of these eye drops and there are reports of non-compliance due to difficulties in inserting these drops, all of which can impact on how effective this treatment regimen is.
The purpose of this study is to assess how well the new automated DSLT device for laser treatment of glaucoma or ocular hypertension works in comparison with the standard SLT and determine that it is as effective in reducing intraocular pressure.
DSLT or SLT will be performed in the study eye according to the randomization assignment. Eligible patients who sign the informed consent will be enrolled at each of the study sites, and undergo a washout (in the case of being medicated). After washout there will be a baseline visit, where continued eligibility is confirmed. Following confirmation of continued eligibility, 50% of patients being randomized to each treatment group. Randomization will be to a pre-determined randomization list.
The un-masked investigator(s) will open the envelope corresponding to the subject ID and administer the treatment as indicated by the randomization envelope. The masked ophthalmologist(s), who will perform the follow up, will be masked as to the nature of the treatment the patient underwent.
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
- Single (Outcomes Assessor)
盲法说明
Intra-ocular pressure (IOP) measurements by masked investigator or masked technique (masked reading).
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 years or older, with visual acuity > 6/60 in both eyes
- •Open angle glaucoma including exfoliative or pigmentary glaucoma or ocular hypertension
- •IOP ≥ 22mmHg to ≤35mmHg (after washout of any IOP-lowering medications)
- •Gonioscopically visible scleral spur for 360 degrees without indentation
- •Ability to visualize the peri-limbal sclera for 360 degrees (using a lid speculum)
- •Willing and able to participate in the 12-month study, to comply with the study procedures and to adhere to the follow-up schedule
- •Participant capable of giving informed consent
排除标准
- •Contraindications to conventional laser trabeculoplasty (e.g. corneal abnormalities, etc.)
- •Angle Closure Glaucoma
- •Congenital or developmental glaucoma
- •Secondary glaucoma except exfoliative or pigmentary glaucoma
- •Presence of any Peripheral Anterior Synechiae (PAS) in the study eye
- •Inability to conduct a reliable visual field (defined as fixation losses, false positives or false negatives greater than 33%)
- •Any of the following visual field findings using the Humphrey visual field analyzer the SITA-standard 24-2 program:
- •A visual field MD of worse than -12dB
- •Greater than or equal to 75% of points depressed below the 5% level and greater than or equal to 50% of points depressed below the 1% level on the PD plot
- •At least 50% of points (i.e 2 or more) within the central 5 degrees with a sensitivity ≤0dB on the decibel plot
- •Points within the central 5 degrees of fixation with a sensitivity <15 dB in both hemifields on the decibel plot
- •A visual field MD of worse than -12dB in the fellow eye
- •Cup:Disc Ratio of more than 0.8
- •More than three hypotensive mediations required
- •Prior incisional or laser glaucoma surgery (including previous SLT) in the study eye
- •Prior corneal refractive surgery
- •Complicated cataract surgery ≤ 6 months prior to enrollment
- •Presence of visually significant cataract in the opinion of the investigator
- •Clinically significant disease in either eye as determined by the Investigator
- •Clinically significant amblyopia in either eye
- •Dense pigmentation or haemorrhage in the peri-limbal conjunctiva or anterior sclera
- •Women who are pregnant or may become pregnant during the study
- •In the opinion of the investigator the participant might require other ocular surgery within the 12-month follow-up period, unless for further reduction of their IOP
- •Concurrent treatment with topical, nasal, inhaled or systemic steroids
- •Uncontrolled systemic disease that could impact the ability of the participant to attend follow up visits as per the discretion of the investigator
- •Participation in another clinical study
结局指标
主要结局
The difference between the two treatment groups between the mean baseline IOP and the mean IOP after the treatment
时间窗: 6 months
The mean baseline IOP (washed out for medicated patients) will be compared to the mean (washed out for medicated patients) IOP after the treatment
次要结局
- Proportion of subjects with at least 20% reduction in IOP from baseline(6 months)
- Number of medications as compare to screening visit(6 months)