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临床试验/NCT07060196
NCT07060196尚未招募不适用

The Impact of Artificial Lighting on the Visual Capacity of Patients With Age-Related Macular Degeneration.

Democritus University of Thrace1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年6月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
1
主要终点
ADL score

研究概览

简要总结

Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss in the elderly worldwide. The dry, non-exudative form of the disease, although more common, is associated with gradual and significant decline in functional vision. Despite advancements in diagnostic and therapeutic approaches, a targeted intervention that improves the daily functionality of these patients is still lacking. One critical, yet often overlooked, factor that affects daily performance is lighting conditions.

This study aims to objectively assess the impact of different lighting intensity levels on patients with advanced dry AMD during the execution of everyday activities. A total of 60 individuals will be evaluated (30 healthy controls over 60 years of age and 30 patients with clinically diagnosed advanced AMD, according to NICE and AREDS criteria). Participants will undergo ophthalmological assessment (visual acuity, contrast sensitivity, OCT/OCTA, autofluorescence), and their performance on five functional tasks (mobility, object grasping, sit-to-stand transition, obstacle avoidance, and hanging clothes) will be evaluated under eight lighting levels (20-300 lux) at a constant color temperature (4000K), in a specially designed laboratory equipped with motion and eye-tracking systems.

The primary endpoint is overall performance, based on task completion time and errors, expressed on a custom performance scale (0-100). Secondary data include changes in pupil size as an indicator of visual adaptation. The study aims to determine the optimal lighting range that maximizes functional vision and improves the quality of life for patients with AMD.

详细描述

Introduction Aging is associated with an increased prevalence of neurodegenerative disorders and leads to irreversible changes in both humans and animal models. The retina, a layer of neural tissue that lines the interior of the eyeball, is exposed to various harmful and stressful environmental factors, including age-related changes, which affect its function. Age-related macular degeneration (AMD) is the leading cause of visual decline and blindness worldwide in individuals aged 65 years and older. The number of patients suffering from AMD is expected to increase significantly in the coming decades. AMD primarily affects the macular region of the retina, which is responsible for central vision. It has a significant impact on patients' lives due to the loss of sharp and color vision, interfering with daily activities such as recognizing faces and reading.

To date, there is no proven treatment that slows or prevents the progression of advanced AMD. Laser photocoagulation and photodynamic therapy reduce the risk of moderate or severe vision loss in some individuals with the neovascular form of the disease. Other medical and surgical interventions are under investigation, but none have been shown to be effective. Identifying the exact pathophysiological mechanisms of AMD remains challenging. However, clinico-pathological observations and epidemiological studies have provided valuable insights into potential pathways involved in AMD development. AMD is generally classified into two forms: non-exudative (dry or atrophic) and exudative (wet).

Exudative AMD is characterized by the development of choroidal neovascularization (CNV), i.e., fibrovascular tissue that grows from the choriocapillaris, penetrates through breaks in Bruch's membrane into the sub-retinal pigment epithelium (RPE) space, and then under the neurosensory retina. Dry AMD involves dysfunction in the RPE-Bruch's membrane-choriocapillaris complex, resulting in lesions such as drusen (small, yellow-white deposits located mainly in the macular area), focal pigment clumping, and RPE atrophy. The most severe atrophic lesion observed in AMD is geographic atrophy, characterized by a well-demarcated round or oval area of depigmentation or clear absence of RPE cells.

The wet form of AMD represents less than 10% of cases but can lead to severe complications if untreated. The latest approach in CNV treatment includes intravitreal injections of anti-angiogenic agents. Vascular Endothelial Growth Factor (VEGF) plays a key role in angiogenesis and in the development of all forms of wet AMD, regardless of angiographic appearance, and increases vascular permeability. Anti-VEGF drugs aim to inhibit VEGF activity, thereby suppressing neovascular growth and reducing vascular leakage. However, this therapy merely delays disease progression. Thus, there is a need for novel preventive and therapeutic strategies targeting AMD.

One factor influencing AMD patients' ability to perform daily activities is lighting conditions. According to current literature, the ideal lighting conditions for AMD patients have not yet been thoroughly studied. Recently, our research team published a pioneering mathematical model to determine optimal lighting intensity in phakic and pseudophakic patients. Identifying optimal lighting for AMD patients could greatly enhance their quality of life.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
60 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy controls over the age of
  • Diagnosis of bilateral dry age-related macular degeneration (AMD).

排除标准

  • Patients with other ocular conditions such as high myopia, glaucoma, clinically significant diabetic retinopathy, and other diseases that may confound the evaluation of ocular outcome measurements.
  • Patients who have undergone intraocular surgeries, except for uncomplicated cataract extraction surgery performed at least 3 months prior to their inclusion in the study.
  • Individuals with systemic diseases, including oxalate kidney stones, Wilson's disease, hemochromatosis, lung cancer, or other illnesses associated with poor five-year survival.
  • Patients with binocular best-corrected distance visual acuity less than or equal to hand motion perception.
  • Patients with neurological, orthopedic, or psychiatric disorders that prevent them from completing the activities or conditions that may affect their performance.

结局指标

主要结局

ADL score

时间窗: On the same day as clinical evaluation, approximately 2-4 hours following baseline assessments.

Each participant's activity score will be calculated based on task completion time and errors. Errors will incur time penalties. A total completion time will be derived for each activity under each lighting condition. A custom scoring scale from 0 (lowest) to 100 (highest) will be developed. Each participant's performance score will be generated from this scale, determining the optimal lighting condition for AMD patients.

次要结局

  • Pupil Size(On the same day as clinical evaluation, approximately 2-4 hours following baseline assessments.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Georgios Labiris

Associate Professor of Ophthalmology

Democritus University of Thrace

研究点 (1)

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