Pilot Study to Evaluate Clinically the Short-Term Efficacy of GlaucoT Glaucoma Treatment Glasses in the Treatment of Primary Open-Angle Glaucoma (GlaucoT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Frequency of the adverse events
研究概览
简要总结
Glaucoma is a chronic and progressive optic neuropathy characterized by degeneration of ganglion cells and axons with loss of visual function.
It is estimated that glaucoma, which is the second cause of preventable blindness in the world, affects nearly 60 million people worldwide.
The most common type of glaucoma is primary open-angle glaucoma (POAG). POAG is a chronic progressive optic neuropathy with characteristic morphological changes in the optic nerve head and retinal nerve fiber.
POAG, progressive retinal ganglion cell death and visual field loss are associated with these changes.
Risk factors for POAG are age, race, high intraocular pressure (IOP), family history of glaucoma, thin central corneal thickness (CCT), high myopia. IOP is the only modifiable risk factor that we can control. For this reason, the priority in the treatment of POAG has always been to reduce IOP. In glaucoma, the essential point is to preserve the damaged ganglion cell layer and therefore the visual functions. In addition to clinical examination, visual field measurements that measure functions, optical coherence tomography (OCT) thickness measurements that measure anatomical changes, and optic nerve head parameters are the most reliable methods for both diagnosis and evaluation of the efficacy of treatment.
Following the results of the visual field and OCT measurements, it will be tried to determine to what extent glaucoma damage can be ceased by the developed GlaucoT glaucoma treatment glasses.
In this study, it is aimed to measure the effectiveness and safety of flicker light therapy, the effectiveness of which has been investigated in the treatment of Alzheimer's previously and has clinically significant results, with the GlaucoT glaucoma treatment glasses, which was developed to cease visual field loss with patient comfort at the forefront and at a lower cost.
详细描述
Background:
Glaucoma, a neurodegenerative disease, is characterized by the death of retinal ganglion cells and their axons. This damage affects all visual pathways up to the visual center in the brain.
Although increased intraocular pressure is considered the most important modifiable risk factor in glaucoma, many factors play a role in its pathogenesis and progression.
Different classifications have been proposed for various types of glaucoma. Accordingly, glaucoma;
- Open angle or closed angle depending on the iridocorneal angle,
- Primary or secondary, depending on the presence of etiological factors that may cause increased intraocular pressure,
- According to the age of onset of glaucoma, it can be classified as congenital, childhood or adult glaucoma.
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 (Participant)
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
- •Inclusion criteria for subject selection
- •Those who have applied to the eye diseases clinic
- •≥18 years old
- •Those diagnosed with primary open-angle glaucoma (POAG) before the study
- •Recipients of standard drug therapy (defined in diagnostic and treatment guidelines) for POAG
- •Patients deemed appropriate by the investigator to be included in the study after ophthalmological examination
- •According to the results of intraocular pressure (IOP) measurement and visual field test, patients with target pressure and initial moderate visual field loss who were deemed appropriate for inclusion in the study by the investigator
- •Patients who were informed about the study and agreed to participate in the study
- •Those who agree to continue to use acceptable methods of contraception during the study
排除标准
- •Exclusion criteria for selection of subjects
- •Those with a history of trauma or inflammation in their eyes
- •Those who have undergone intraocular surgery or laser in the last 6 months, excluding those who have had uncomplicated cataract surgery
- •Presence of any retinal or neurological disease other than glaucoma, abnormal ocular motility preventing binocular fixation (eg, nystagmus, strabismus)
- •Those with corneal transplants
- •Advanced disc cupping (c/d ratio 0.8 and above)
- •Large and severe perimetric defects (a central perimetric residual not greater than 10 central degrees)
- •Advanced visual field damage (MD above 12 db)
- •Dry/wet type age-related macular degeneration in one or both eyes
- •Those who have had glaucoma surgery in the past, excluding laser
- •Corneal dystrophies
- •High myopia (more than 6 diopters)
- •Peripheral retinal degenerations with risk of retinal detachment
- •Keratitis
- •Those with severe dry eye syndrome
- •Those with neurological disorders (eg, epilepsy)
- •Those with systemic diseases (eg, diabetic mellitus)
- •Women who are pregnant supported by biochemical laboratory findings
- •Patients with difficulties in understanding and adapting to the study
- •Negative benefit/risk ratio determined by the investigator
- •Participated in any clinical trial within the previous 30 days.
研究组 & 干预措施
Gamma Rhythm Stimulation Group
Evaluation of the efficacy and safety of GlaucoT in patients with primary open-angle glaucoma (POAG).
In this study, it was planned to investigate the effect of reducing the progression of glaucomatous damage by applying 40 Hz flicker light therapy for 1 hour a day to POAG patients. It is planned to use visual field test, measurements of retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) layer thicknesses in optical coherence tomography to investigate the effectiveness of the treatment.
干预措施: GlaucoT Glaucoma Treatment Device (Device)
Control Group
This group will be monitored without using the device.The data will be used only for comparison.
Considering the sample size calculations and losses, a total of 60 patients are planned to be included in the study, with 30 patients in each group.
结局指标
主要结局
Frequency of the adverse events
时间窗: 6 months
In our study, the safety of the GlaucoT glasses with flickering light treatment will be assessed. The purpose of the treatment is to provide neuroprotection with flickering light treatment. The primary outcome for safety of the device is the frequency of the adverse events.
The stabilization in visual field test
时间窗: 6 months
The second outcome of the clinical trials will be the efficacy of the GlaucoT device. The differences between the patients who use GlaucoT will be compared with the ones that do not use the device under same conditions (e.g. drug use). The assessment will be based on visual field test.
次要结局
未报告次要终点