跳至主要内容
临床试验/NCT01233908
NCT01233908已完成不适用

Diagnosis of Posttraumatic Stress Disorder Following Primary Rhegmatogenous Retinal Detachment

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 547 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
547
试验地点
1
主要终点
Diagnosis of posttraumatic stress disorder

研究概览

简要总结

To investigate the prevalence of posttraumatic stress disorder (PTSD) in patients that underwent surgery for primary rhegmatogenous retinal detachment (RRD) and to determine variables associated with the disorder.

Design: Consecutive prospective observational study.

详细描述

Rhegmatogenous retinal detachment (RRD) is a potentially blinding condition and a common cause of ocular morbidity, with an estimated incidence of 6.3-17.9 per 100,000 of population. 1 Despite contemporary surgical treatments, with nearly 95% of anatomical success, functional results for the repair of primary RRD remain poor, with only 43% achieving a final vision ≥ 20/40 and 21% a visual acuity (VA) < 20/100. 2 Various studies of vision related quality of life after RRD have demonstrated that RRD subjects suffer with substantial impairment of physical, psychological and social functions. 3-6 Mozaffarieh et al. further demonstrated that these subjects suffer of anxiety and depression, with correlation to visual functional status. 7 However, to date, no study have assessed the occurrence of primary RRD as a traumatic event that may trigger an associated distress disorder.

Post traumatic distress disorder (PTSD) is diagnosed after a subject is exposed to an extreme stressor or traumatic event, which resulted with response of fear, helplessness, or horror, and caused typical symptoms of reexperiencing of the event, avoidance of reminders of the event, and increased arousal, for at least one month (Table 1). 8 PTSD was found to occur in the aftermath of external traumas, such as rape, physical assault, combat and natural disasters. 9 However, various illnesses were described as well, as triggering events, after which PTSD developed: myocardial infarction (MI), 10 abortions, 11, 12 cancer, 13 diagnosis of HIV infection, 14 and pulmonary diseases. 15, 16 The burden of PTSD can be high, with inability to work or return to prior levels of functioning. 17, 18 The work impairment associated with PTSD is estimated to result with an annual productivity loss in excess of $3 billion in the US. 19 Furthermore, PTSD was found to have an impact on physical health, with higher rates of cardiovascular and pulmonary illnesses, 20 and with greater utilization of health care services, 21 all together putting the disorder as a major public health problem.

The purpose of our study was to examine whether the occurrence of a primary RRD can give rise to an associated PTSD, to investigate its prevalence and determine variables associated with the disorder.

Methods:

We approached 547 patients with a previous primary RRD, of which 363 (mean age 58 ± 15 years, 64% were men) were enrolled in the study. PTSD was assessed by the Clinician Administered PTSD Scale and the 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) was used as a measure of vision-related quality of life. Objective clinical measures were obtained from the patient's medical records. Psychological and ophthalmological variables were compared between PTSD diagnosed patients and a subset of PTSD-negative patients, who served as controls.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Above 18 years of age, underwent surgical correction for primary rhegmatogenous retinal detachment, follow up of at least 1 month after surgery

排除标准

  • Poor Hebrew proficiency

结局指标

主要结局

Diagnosis of posttraumatic stress disorder

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (1)

Loading locations...

相似试验