Treatment of Granular Corneal Dystrophy Using Nd-YAG Laser
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in size of granular corneal deposits due to Nd:YAG laser treatment
研究概览
简要总结
Granular Corneal Dystrophy is a rare hereditary disease characterized by the development of deposits within the cornea, which may in turn affect the quality of vision. Still today, all existing treatment options are based on surgical intervention and there is no minimally-invasive treatment available for the disease.
The goal of this clinical trial is to test the effectiveness and safety of Neodymium-doped yttrium aluminum garnet (Nd:YAG) laser as a minimally-invasive treatment for people suffering from Granular Corneal Dystrophy. The main question it aims to answer is if Nd:YAG laser is able to disintegrate the characteristic corneal depositions in a safe manner without causing significant adverse effects.
If found suitable to be part of the study, participants will first undergo a series of imaging studies to measure and characterize the corneal deposits. After completion, the participants will undergo the Nd:YAG laser treatment under local anesthesia by a corneal specialist, targeting deposits not involving the visual axis. Following the treatment, participants might need to take antibiotic eye drops for a duration of approximately one week. The participants will be required to attend two follow-up visits: one week after the treatment and 3 months after the treatment. In each one of the follow-up visits, an eye examination will be performed and the same series of imaging studies that was performed prior to the Nd:YAG laser treatment will be repeated.
详细描述
Neodymium:yttrium aluminum garnet (Nd:YAG) laser is an ophthalmic instrument that finds versatile use in clinical practice since its first introduction in 1980s. This solid-state laser emits infrared light at a wavelength of 1064 nm that can disrupt ocular tissues by causing an optical breakdown with a short, high-power pulse. Thanks to its high precision, minimal-invasive mode of delivery, and well-established safety profile, its application ranges from treatment of posterior capsule opacification, chronic and acute angle-closure glaucoma, vitreous floaters, to proliferative diabetic retinopathy.
Granular corneal dystrophy (GCD) is a rare hereditary condition characterized by progressive deposition of insoluble protein aggregates in the cornea. The small, white-greyish granular deposits typically begin to form during childhood and grow in size and number with increasing age, eventually coalescing and causing significant visual impairment.
Still today, there is no minimal-invasive treatment available for GCD patients. Current treatment approaches include partial or full-thickness corneal transplant, which is associated with a relatively high recurrence rate and potentially sight-threatening complications. In addition, there is a global shortage of available donor corneas. Therefore, there is an unmet need for a minimal-invasive treatment that could reduce this indication for corneal transplantation and provide symptomatic relief to GCD patients.
As modern Nd:YAG laser systems can focus on a spot size as small as 8-10 µm in different depths of the cornea, the study team hypothesize that the Nd:YAG laser would be capable of accurately targeting the GCD deposits and serve as a viable minimal-invasive treatment option for this disease.
Hence, in the proposed research, the investigators seek to evaluate the efficacy and safety of the Nd:YAG laser in the treatment of GCD patients. If found to be efficacious and safe, the investigators hypothesize that GCD patients will benefit from both the minimal-invasive form of treatment and prompt improvement in quality of life and vision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Patients older than 18 years of age
- •Diagnosis of granular corneal dystrophy with presence of granular opacities in the peripheral cornea of appropriate size (ca. 50 µm) in at least one eye
- •Willingness and ability to give signed informed consent and follow study instructions
排除标准
- •Presence of any active intra-ocular inflammation
- •Pre-existing glaucoma or retinal edema
- •Cannot properly self-administer or receive an eye drop medication
结局指标
主要结局
Change in size of granular corneal deposits due to Nd:YAG laser treatment
时间窗: Baseline, Post-intervention day 7, Post-intervention 3 months
The size of each one of the two treated corneal deposits per participant will be measured in µm on images taken by both the AS-OCT and slit-lamp photography in each study visit. The size will be measured both manually and automatically on each one of the imaging techniques. A comparison of the size between study visits will be performed, change from day 7 post-intervention to month 3 post-intervention.
次要结局
- Safety as the number participants experiencing adverse events of inflammation and/or scarring(Post-intervention day 7, Post-intervention 3 months)
- Safety as the number of participants experiencing decrease in visual acuity(Baseline, Post-intervention day 7, Post-intervention 3 months)