Prevalence Analysis of Ocular Disorders in Patients on Treatment for Symptomatic Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- To assess prevalence of reduced visual acuity (>/= 20/40), cataract (graded according to LOCS III grading scale), dry eye, retinopathy, elevated intraocular pressure (> 21 mmHg) in patients on treatment for Multiple Myeloma
研究概览
简要总结
Overall survival of multiple myeloma (MM) patients has increased significantly due to the availability of the new drugs. Moreover, since MM is an incurable disease, patients are exposed to repeated lines of therapy with different agents. It is therefore increasingly important to monitor the long-term side-effects of treatments. In the present study we focused on ocular disorders. This is an observational study aiming to assess the prevalence of ocular disorders in 100 patients on treatment or follow-up for MM.
详细描述
This is an observational study aiming to assess the prevalence of ocular disorders in patients on treatment or follow-up for MM.
Study population Patients diagnosed with multiple myeloma on treatment and/or on follow-up after treatment for multiple myeloma. The study aims to enroll 100 patients.
Endpoints Primary endpoint: To determinate prevalence and main characteristics of ocular disorders in patients on treatment / or previously treated for Multiple Myeloma.
Secondary endpoints:
- To evaluate the relation between the kind of treatment for multiple myeloma and the development of ocular disorders
- To evaluate the relation between patient's characteristics and comorbidities (such as sex, age, smoking, hypertension, diabetes, autoimmune diseases) and the presence of ocular disorders in this population of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Age > 18 years
- •Diagnosis of Multiple Myeloma
- •Patients have started an active treatment for Multiple Myeloma since at least two months
- •Patients on active treatment for relapsed/refractory multiple myeloma
- •Patients on follow-up after previous active treatment for multiple myeloma
排除标准
- •Bilateral blindness preceding the diagnosis of multiple myeloma
- •No signature of the informed consent
- •Patients have started an active treatment for Multiple Myeloma since less than two months
结局指标
主要结局
To assess prevalence of reduced visual acuity (>/= 20/40), cataract (graded according to LOCS III grading scale), dry eye, retinopathy, elevated intraocular pressure (> 21 mmHg) in patients on treatment for Multiple Myeloma
时间窗: 12 months
次要结局
未报告次要终点
研究者
Vittorio Montefusco
Medical Doctor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano