New Horizons in the Treatment of Vitreous Floaters: Efficacy and Safety of Vitreolysis With the Ultra Q Reflex YAG Laser (Ellex)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Utility Value Score
研究概览
简要总结
The Ultra Q Reflex® (Ellex) constitutes the only Nd:YAG laser approved for the treatment of vitreous floaters. No randomized controlled clinical trial has been carried out to this day in order to investigate its superiority over sham treatment.
In the present study, 60 eyes will be randomized and blinded into 2 groups, one receiving up to two sessions of laser vitreolysis the other scheduled for two sessions of sham treatment. After a maximum of two (sham) treatment sessions (1 per month), patients' utility value score and BCVA will be re-assessed. A follow-up period of 12 months (with visits at month 1, 6 and 12 post-treatment) will ensue the "treatment phase" to register any late adverse events that may be associated with laser vitreolysis.
As vitrectomy constitutes a highly invasive procedure, which must therefore be restricted to severe cases only, laser vitreolysis may present a valuable treatment option for patients with moderate vitreous floaters that are not eligible for vitrectomy.
详细描述
A great number of patients seek out their ophthalmologists when troubled by vitreous floaters. The majority of these patients are reassured when the diagnosis is made and are content to get accustomed to these "mouches volantes". A considerable proportion, however, feels permanently irritated by vitreous floaters which may result in a significant decrease of patients' quality of life.
Until recently, pars plana vitrectomy constituted the only established therapeutic option. Though a standard surgical procedure, the potential adverse events associated with vitrectomy are not negligible and patients must allow for an extended period of visual rehabilitation. Therefore, treatment was restricted to severe cases and thus only a very small percentage of patients received any treatment at all.
Reports exist on Q-switched Nd:YAG laser surgery for vitreous opacities, membranes and vitreoretinal bands in 59 eyes. The results of early laser vitreolysis are sobering with an improve in visual acuity in only 18 eyes but considerable adverse events such as retinal holes with detachment (1 eye), minor retinal hemorrhages (4 eyes) and focal opacities of the crystalline lens (5 eyes).
According to another study, the Q-switched system allowed treatment of a wider variety of indications in the posterior pole and requires fewer sessions when compared to a mode-locked system. Due to the higher energy levels required by Q-switch system, however, complications occurred more frequently.
An additional study presented more favorable results; in all 15 cases the symptoms of vitreous floaters disappeared after treatment and no adverse events were reported during a follow-up period of at least 1 year. Nevertheless, the reported energy levels (5-7.1mJ and total energy 71-742mJ) were considerable.
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)
入排标准
- 年龄范围
- 18 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the subject's written consent to participate in the present study
- •considerable impairment of quality of life (defined as utility value score ≤ 0.7) due to floater-related symptoms for at least 3 months prior to inclusion
- •floaters must be located at a safe distance to both the retina and the intraocular lens - preferably in the middle third of the vitreous
- •pseudophakic eyes
- •age >18 years
排除标准
- •phakic eyes
- •any retinal pathology and/or other ocular condition (including but not limited to amblyopia, pathologies of the cornea, glaucoma/history of elevated intraocular pressure) that may prevent or reduce a potential increase in visual acuity and/or decrease of the utility value score and/or incur an increased likelihood of adverse events.
- •any ocular or systemic condition that may result in an impaired feasibility of the study treatment and/or required examinations.
结局指标
主要结局
Utility Value Score
时间窗: 1-6 months
Subjective Assessment of Impairment due to floaters
次要结局
未报告次要终点