NCT01233908|Completed
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Sponsor study identifier
observational
547
1 country
1
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2010
Actual (reported)Study Completion
September 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2010
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
September 2010
Actual (reported)September 2010
Actual (reported)November 2, 2010
Actual (reported)November 3, 2010
Actual (reported)Diagnosis of posttraumatic stress disorder
Patients which underwent surgical repair for primary rhegmatogenous retinal detachment and developed an associated posttraumatic stress disorder
Patients which underwent surgical repair for primary rhegmatogenous retinal detachment and did not develope an associated posttraumatic stress disorder
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
Goldschleger institute of ophthalmology, Sheba medical center
Ramat Gan, Israel
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.
Ido Didi Fabian, MD
Chaim Sheba medical center
547 participants (actual enrollment reported by the registry).
First Submitted
November 2, 2010
First Posted
November 3, 2010
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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.
Primary Completion
September 2010
Actual (reported)Study Completion
September 2010
Actual (reported)Last Updated
November 3, 2010
Record last verified: 2010-11
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