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IRCT20200620047837N1 IRCT 2020-08-08 Shiraz University of Medical Sciences Effect of Intra-silicon oil Triamcinolone acetonide on macular anatomy in rhegmatogenous retinal detachment Survey the effect of intra-silicon oil Triamcinolone acetonide on macular anatomy after vitrectomy for rhegmatogenous retinal detachment 2020-06-27 anticipated 60 Complete https://irct.ir/trial/49025 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by blocked method. 6 persons will place in every block equally. Randomization chart will be used as randomization tool, Blinding description: The participants don't have any information about the group they participate in. No information will be registered on operation note and follow up note about injection of Triamcinolone acetonide in both groups. Every patient will be known by a special code witch only the investigator knows that code belongs to which group. Also analizer and evaluator of consequences are unaware about codes and their specification to every group. N/A Rhegmatogenous retinal detachment. Intervention 1: Intervention group: Injection of 1 time Triamcinolone acetonide within sclerotmy site by dose of 1 mg/0.05 cc from 40mg ampoule made by Alborz Darou company at end of vitrectomy and silicon oil injection operation. Intervention 2: Control group:Triamcinolone acetonide is not injected. Other procedures are identical to intervention group. Yes - There is a plan to make this available What will be shared: Due to all gathered data from patients evaluate unknownly, all these informations are sharable totally. When: 6 months after publication To whom: People working in academic institutions Conditions: Evauation of survey and gathering data method Where to obtain: Email to Nowroozzadeh@hotmail.com Refer or contact to Poostchi ophthalmology research center dependent on Shiraz university of medical sciences, phone number: 0098 7132302830, Fax: 0098 7132355936 How to obtain: At first contact to Nowroozzadeh@hotmail.com and send your request; then contact to Poostchi ophthalmology research center dependent on Shiraz university of medical sciences, phone number: 0098 7132302830, Fax: 0098 7132355936 Comments:
public Mohammad hosein Nowroozzadeh, MD
Khalili hospital, Khalili Ave., Mollasadra street, Shiraz
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3629 1470 Nowroozzadeh@hotmail.com Shiraz University of Medical Sciences scientific Mohammd hosein Nowroozzadeh MD
Khalili hospital, Khalili Ave., Mollasadra street, Shiraz
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3629 1470 Nowroozzadeh@hotmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age more than 18 year old Rhegmatogenous retinal detachment involving macula Need for vitrectomy surgery and silicon oil injection Less than 1month since symptoms initiation 18 years no limit Both Aphakia Pseudophakia with previous complicated catatract surgery Any complication during previous occular surgeries Previous scleral buckling surgery, pneumatic surgery and vitrectomy surgery Diabetic retinopathy Axial length more than 26 mm or less than 20 mm Abnormal optic disk Need to retinotomy History of uveitis Glucoma or IOP more than 21 mm Hg before operation Abnormal retina such as coloboma and choroidal detachment Tractional retinal detachment Vitreous hemorrhage History of anti-VEGF injection H33.0 Retinal detachment with retinal break Treatment - Drugs Treatment - Drugs Intervention group: Injection of 1 time Triamcinolone acetonide within sclerotmy site by dose of 1 mg/0.05 cc from 40mg ampoule made by Alborz Darou company at end of vitrectomy and silicon oil injection operation Control group:Triamcinolone acetonide is not injected. Other procedures are identical to intervention group. Macular thickness. Timepoint: Before operatio; 1, 3 and 6 months after operation. Method of measurement: Macular OCT with Heidelberg. Vice chancellor of Shiraz University of Medical Sciences Approved 2020-02-22 Ethics committee of Shiraz University of Medical Sciences Shiraz university of Medical Sciences central building, Zand Blvd, shiraz Shiraz Fars Iran (Islamic Republic of)