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IRCT20191207045645N1 IRCT 2020-06-08 Vice Chancellor for Research, Iran University of Medical Sciences statin in PVR related redetachment Possible effect of statin use on the occurrence of retinal detachment secondary to PVR in patients with a history of successful vitrectomy or scleral buckling surgery referred to Rassoul Akram Ophthalmology Clinic, Randomized Clinical Trial 2019-12-16 anticipated 110 Complete https://irct.ir/trial/45721 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: online randomization system (https:// www.randomization.com) block randomization block size: 4 with 1 by 1 proportion, Blinding description: The study participants were not aware of the intervention type because the main drug and placebo were not distinguishable. The principal investigator who evaluates the outcome is also unaware of the type of intervention because the medication is prescribed by another person performing the randomization. The analyzer is also supposed to analyze the data as two groups a and b, the type of intervention is unknown. 3 secondary retinal detachment. Intervention 1: Intervention Group: Use of Atorvastatin 40 mg (Actover Pharmaceutical Company) daily for 3 months after successful vitrectomy or scleral buckling surgery for retinal detachment. Intervention 2: Control group: Use of placebo (Actover Pharmaceutical Company) daily for 3 months after successful vitrectomy or scleral buckling surgery for retinal detachment. Yes - There is a plan to make this available What will be shared: clinical data and examination without any clue of patients identifications are available When: after registry of all date (2 months after the last examination) To whom: all staff related to the university Conditions: clinical data and examination and analysis results without any clue of patients identifications are available Where to obtain: Fateme Abdi How to obtain: A written request will be received by Dr. Fatemeh Abdi and regarding the request, the time of publishment will be announced Comments:
public Fatemeh Abdi
Hazrat e Raool Akram hospital, Sattarkhan
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2473 fatemeh.abdi62@yahoo.com Iran University of Medical Sciences scientific Fatemeh Abdi
Hazrat e Raool Akram hospital, Sattarkhan
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2473 fatemeh.abdi62@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) age>40 primary attachment following PPV with silicon oil or sf6 tamponade vs scleral buckle regular follow up all of the surgery was done with a single experienced surgeon in a single center 40 years no limit Both combined RD recurrent RD RRD associated with giant tear Secondary RD due to other than PVR intraoperative complications like vitreous or suprachoroidal hemorrhages Other concomitant eye diseases affecting the retina including glaucoma, CSR, acquired and congenital retinal dystrophies, etc. PVRc lactation and pregnancy systemic steroid use Taking different medications that can interfere with statin use H33.0 Retinal detachment with retinal break Treatment - Drugs Placebo Intervention Group: Use of Atorvastatin 40 mg (Actover Pharmaceutical Company) daily for 3 months after successful vitrectomy or scleral buckling surgery for retinal detachment. Control group: Use of placebo (Actover Pharmaceutical Company) daily for 3 months after successful vitrectomy or scleral buckling surgery for retinal detachment. Secondary retinal detachment. Timepoint: 1 day, 1 week and 1,3 and 6 months after the surgery. Method of measurement: examinations and OCT imaging. Comparing the rate of retinal detachment in groups of using statin and using placebo. Timepoint: day 1, week 1, month 1,3 and 6. Method of measurement: slit lamp examination and OCT. Vice Chancellor for Research, Iran University of Medical Sciences Approved 2019-12-16 Ethical committee of Iran university of medical science Iran university of medical science, Hemmat highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)