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临床试验/NCT07191847
NCT07191847招募中4 期

CaraClear, Studying Lens Peptides and Extra Ocular Tissue Managed by ACE Pico Protocol in Tear Film Stability, Tear Volume, and Dry Eye Symptoms Using Stem Cells Fortified Eye Drops

Ace Cells Lab Limited1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年4月22日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
招募中
入组人数
300
试验地点
1
主要终点
Slit-lamp grading + AS-OCT (structural clarity)

研究概览

简要总结

Dry Eye Disease (DED) is a multifactorial condition that affects the ocular surface, leading to discomfort, tear film instability, and potential visual disturbances. Its global prevalence ranges between 5% and 50%, making it a significant cause of reduced quality of life and a growing burden on healthcare systems. Cataract, defined as a progressive opacification of the lens, remains the leading cause of preventable blindness worldwide, responsible for about 33% of all cases, affecting an estimated 94 million people. Its incidence increases with age and is influenced by factors such as ultraviolet exposure, diabetes, smoking, and genetic predisposition. Low- and middle-income countries (LMICs) face a disproportionately high burden due to limited access to surgical care. The economic impact of cataract is profound, including both direct costs (surgery, post-op care) and indirect costs (lost productivity, caregiver dependency), with global productivity losses estimated at $53 billion annually. Beyond economics, cataract significantly impairs quality of life, contributing to psychological distress, depression, loss of independence, and increased risk of cognitive decline. Addressing this burden requires integrated strategies that ensure equitable access to treatment, reduce financial barriers, and include psychosocial support. In parallel, emerging regenerative therapies such as stem cell-fortified eye drops offer new hope. These treatments, utilizing mesenchymal stem cells (MSCs), aim to restore ocular surface health in conditions like DED by reducing inflammation and enhancing tissue repair. The current study evaluates the efficacy of such drops in improving tear film stability, tear volume, and overall clinical symptoms using advanced diagnostic tools.

详细描述

Dry eye disease (DED) is a multifactorial condition affecting the ocular surface, characterized by symptoms of discomfort, visual disturbances, tear film instability, and potential damage to the ocular surface. DED impacts patients' quality of life and poses a significant healthcare burden, with an estimated global prevalence ranging from 5% to 50%.

Cataract, a progressive opacification of the ocular lens leading to visual impairment, remains the foremost cause of preventable blindness globally, constituting a significant public health burden. According to the World Health Organization (WHO), an estimated 94 million individuals worldwide are affected by cataract-related visual disability, with the condition accounting for approximately 33% of all cases of blindness. The prevalence of cataract exhibits marked demographic and geographic heterogeneity, correlating strongly with advancing age, ultraviolet radiation exposure, metabolic disorders (e.g., diabetes mellitus), tobacco use, and genetic predisposition. While age-related cataracts dominate in populations over 50 years, congenital and traumatic forms contribute to morbidity across all age cohorts. Low- and middle-income countries (LMICs) bear a disproportionate burden, with cataract blindness rates up to threefold higher than in high-income regions due to limited access to surgical interventions and preventive care.

The socioeconomic ramifications of cataract-induced visual impairment are profound. Direct costs, including surgical expenses, postoperative care, and corrective devices, impose substantial financial strain on healthcare systems and households, particularly in resource-limited settings. Indirect costs, such as lost labor productivity, caregiver dependency, and reduced educational attainment, further exacerbate economic disparities. In LMICs, where out-of-pocket expenditures dominate healthcare financing, cost-related barriers delay surgical treatment, perpetuating cycles of disability and poverty. A meta-analysis estimated annual global productivity losses attributable to cataract at $53 billion, underscoring its macroeconomic impact.

Concurrently, cataract-associated visual decline engenders significant psychological morbidity. Patients frequently report diminished quality of life (QoL), characterized by heightened anxiety, depression, and social isolation due to functional limitations in daily activities (e.g., mobility, self-care). The loss of independence, particularly among elderly populations, exacerbates feelings of helplessness and stigmatization. Furthermore, delayed intervention correlates with irreversible neuroadaptive changes in the visual cortex, compounding psychological distress. Emerging evidence also highlights the bidirectional relationship between cataract-related disability and mental health disorders, with untreated visual impairment increasing susceptibility to cognitive decline and dementia.

Addressing the global cataract burden necessitates integrated strategies that combine equitable access to surgical care, cost-reduction initiatives, and psychosocial support systems. Understanding the interplay of epidemiological, economic, and mental health dimensions is critical to mitigating its multisectoral impact on human health and societal well-being.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-80 years.
  • Diagnosed with dry eye disease (based on clinical criteria such as OSDI scores and Schirmer test results).

排除标准

  • Exclusion Criteria:
  • History of ocular surgery or trauma.
  • Other ocular diseases (e.g., glaucoma, keratitis).
  • Systemic conditions that may interfere with study outcomes (e.g., autoimmune diseases).

研究组 & 干预措施

corneal opacity clearing

Other

selecting the cases of corneal opacity and treat with 2 drops 3 times daily for 12 weeks

干预措施: eye drops (Biological)

结局指标

主要结局

Slit-lamp grading + AS-OCT (structural clarity)

时间窗: 12 weeks

Assess the therapeutic efficacy of stem cell-fortified eye drops in the corneal opacity

次要结局

  • BCVA (functional improvement)(12 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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