- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01233908
Diagnosis of Posttraumatic Stress Disorder Following Primary Rhegmatogenous Retinal Detachment
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.
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ramat Gan, Israel
- Goldschleger institute of ophthalmology, Sheba medical center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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PTSD
Patients which underwent surgical repair for primary rhegmatogenous retinal detachment and developed an associated posttraumatic stress disorder
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PTSD - negative
Patients which underwent surgical repair for primary rhegmatogenous retinal detachment and did not develope an associated posttraumatic stress disorder
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Diagnosis of posttraumatic stress disorder
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ido Didi Fabian, MD, Chaim Sheba Medical Center
Publications and helpful links
General Publications
- Mitry D, Charteris DG, Fleck BW, Campbell H, Singh J. The epidemiology of rhegmatogenous retinal detachment: geographical variation and clinical associations. Br J Ophthalmol. 2010 Jun;94(6):678-84. doi: 10.1136/bjo.2009.157727. Epub 2009 Jun 9.
- Pastor JC, Fernandez I, Rodriguez de la Rua E, Coco R, Sanabria-Ruiz Colmenares MR, Sanchez-Chicharro D, Martinho R, Ruiz Moreno JM, Garcia Arumi J, Suarez de Figueroa M, Giraldo A, Manzanas L. Surgical outcomes for primary rhegmatogenous retinal detachments in phakic and pseudophakic patients: the Retina 1 Project--report 2. Br J Ophthalmol. 2008 Mar;92(3):378-82. doi: 10.1136/bjo.2007.129437.
- Sullivan PM, Luff AJ, Julious SA, Canning CR. Patient satisfaction following vitreoretinal surgery. Eye (Lond). 1993;7 ( Pt 3):433-5. doi: 10.1038/eye.1993.86.
- Zou H, Zhang X, Xu X, Liu H. Quality of life in subjects with rhegmatogenous retinal detachment. Ophthalmic Epidemiol. 2008 Jul-Aug;15(4):212-7. doi: 10.1080/09286580701843804.
- Globe DR, Levin S, Chang TS, Mackenzie PJ, Azen S. Validity of the SF-12 quality of life instrument in patients with retinal diseases. Ophthalmology. 2002 Oct;109(10):1793-8. doi: 10.1016/s0161-6420(02)01124-7.
- Scott IU, Smiddy WE, Feuer W, Merikansky A. Vitreoretinal surgery outcomes: results of a patient satisfaction/functional status survey. Ophthalmology. 1998 May;105(5):795-803. doi: 10.1016/S0161-6420(98)95017-5.
- Mozaffarieh M, Sacu S, Benesch T, Wedrich A. Mental health measures of anxiety and depression in patients with retinal detachment. Clin Pract Epidemiol Ment Health. 2007 Jul 19;3:10. doi: 10.1186/1745-0179-3-10.
- Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995 Dec;52(12):1048-60. doi: 10.1001/archpsyc.1995.03950240066012.
- Gander ML, von Kanel R. Myocardial infarction and post-traumatic stress disorder: frequency, outcome, and atherosclerotic mechanisms. Eur J Cardiovasc Prev Rehabil. 2006 Apr;13(2):165-72. doi: 10.1097/01.hjr.0000214606.60995.46.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-10-7609-DF-CTIL
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