Diagnosis of Posttraumatic Stress Disorder Following Primary Rhegmatogenous Retinal Detachment

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01233908
First received: November 2, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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.


Condition
Stress Disorders, Post-Traumatic
Retinal Detachment

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Diagnosis of Posttraumatic Stress Disorder Following Primary Rhegmatogenous Retinal Detachment

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Diagnosis of posttraumatic stress disorder [ Designated as safety issue: No ]

Enrollment: 547
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
PTSD
Patients which underwent surgical repair for primary rhegmatogenous retinal detachment and developed an associated posttraumatic stress disorder
PTSD - negative
Patients which underwent surgical repair for primary rhegmatogenous retinal detachment and did not develope an associated posttraumatic stress disorder

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects eligible for the study were subjects, above 18 years of age, who underwent surgical correction for primary rhegmatogenous retinal detachmentat the Goldschleger Eye Institute, from January 1, 2004 to September 31, 2009, and were followed up for at least 1 month

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Poor Hebrew proficiency

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01233908

Locations
Israel
Goldschleger institute of ophthalmology, Sheba medical center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Chair: Ido Didi Fabian, MD Chaim Sheba medical center
  More Information

Publications:

Responsible Party: Ido Didi Fabian, MD, Sheba medical center
ClinicalTrials.gov Identifier: NCT01233908     History of Changes
Other Study ID Numbers: SHEBA-10-7609-DF-CTIL
Study First Received: November 2, 2010
Last Updated: November 2, 2010
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Disease
Retinal Detachment
Anxiety Disorders
Mental Disorders
Pathologic Processes
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 19, 2014