NCT06915922已完成不适用
Therapeutic Neodymium-doped Yttrium-Aluminum-Garnet (Nd:YAG) Laser Vitreolysis for Vitreous Floaters - A Study to Quantify Visual Quality of Life, Vitreous Structure, and Vision Before and After Nd:YAG Laser Vitreolysis in Patients With Vision Degrading Myodesopsia
VMR Consulting, Inc.3 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年10月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- Measures of vitreous structure by quantitative ultrasonography
研究概览
简要总结
The purpose of this study is to measure how the quality of life, the structure of eye, and vision change after treatment for the opacities in the gel (vitreous) that fills the center of eye which cause vision disturbances commonly called "floaters".
In this study the vitreous floaters are treated using a Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser. The FDA has approved the use of this laser to treat membranes in the eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Only one eye per patient will be included in this study
- •Able and willing to give informed consent
- •Age ≥18 years
- •Suffering from symptomatic vitreous floaters
- •Floaters arising from either/both:
- •myopic vitreopathy
- •posterior vitreous detachment
- •Floaters meeting the following characteristics:
- •Present for ≥3 months
- •One single or more dense and well-defined vitreous opacities,
- •A Weiss Ring or opacities which are within the safety area, at least 3mm away from the retina and 6mm away from the lens
- •Visible on contact lens biomicroscopy
排除标准
- •Patient presenting with vitreous opacities outside of the described safety area (within 3mm of the retina or 6mm from the lens)
- •Have clinically significant cataract (lens opacification) in one or both eyes which are in the opinion of the examining doctor more significant in impacting vision as compared to that caused by vitreous opacities; or cataract expected to need cataract surgery during the duration of the study
- •Present with untreated retinal tears or retinal holes requiring treatment at the discretion of the study investigator
- •Have high risk of peripheral lesions requiring treatment at the discretion of the study investigator
- •Have synchysis scintillans (unusual vitreous opacities from old blood)
- •Have asteroid hyalosis (unusual vitreous opacities from cholesterol)
- •Have vitreous hemorrhage (fresh blood in the center of the eye)
- •Have active photopsia (flashing lights)
- •History of previous YAG laser vitreolysis treatments, or vitrectomy for any condition (retinal detachment, proliferative diabetic retinopathy, etc.)
- •Have Posterior Vitreous Detachment (separation of vitreous away from the retina lining the inside of the back of the eye) within the past 3 months
- •Are unable to attend study appointments
- •Have any other significant ocular or non-ocular condition that, at the discretion of the study investigator, puts the subject at risk or influences the results of the study
- •History of intraocular surgery within 6 months from study entry
- •History of retinal laser within 2 months from study entry
研究组 & 干预措施
Neodymium-doped Yttrium-Aluminum-Garnet (Nd:YAG) Laser Vitreolysis
Other
干预措施: Neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser therapy (Device)
结局指标
主要结局
Measures of vitreous structure by quantitative ultrasonography
时间窗: baseline, 3 months, 6 months, 12 months
次要结局
- Measures of visual function using contrast sensitivity(baseline, 3 months, 6 months, 12 months)
- Evaluation of quality of life using Visual Function Questionnaire (VFQ-25)(baseline, 3 months, 6 months, 12 months)
- Evaluation of quality of life using Vitreous Floater Functional Questionnaire (VFFQ)(baseline, 3 months, 6 months, 12 months)
- Evaluation of Visual Acuity (ETDRS LogMAR)(baseline, 3 months, 6 months, 12 months)
- Evaluation of Near Visual Acuity(baseline, 3 months, 6 months, 12 months)
- Evaluation of retinal electrical activity changes in response to light stimuli (Photopic Negative Response amplitude) using Electroretinography (ERG)(baseline, 3 months, 6 months, 12 months)
- Visual evaluation of retinal structure changes in sagittal mode using optical coherence tomography (OCT) centered on the fovea(baseline, 3 months, 6 months, 12 months)
- Evaluation of central visual field changes (median light sensitivity) using microperimetry(baseline, 3 months, 6 months, 12 months)
研究者
研究点 (3)
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