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IRCT20201120049450N4 IRCT 2024-04-12 Shiraz University of Medical Sciences Effect of intravitreal triamsinolone injection on macular anatomy Effect of adjuvant intraoperative intravitreal triamcinolone on the optical coherence tomography-wise macular anatomy following vitrectomy for epiretinal membrane: a Randomized clinical trial 2023-12-11 anticipated 40 Complete https://irct.ir/trial/70156 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method will be used to generate the random allocation sequence is block randomization (A: intervention group & B: control group  blocks: AABB, ABBA, BABA,BBAA, BAAB, ABAB); By using free online random sequence generator (www.sealedenvelope.com) block randomization was done with quaternary blocks. Random allocation sequencing was done by statistics specialist, Blinding description: participants, Outcome assessors and data analyzer will be blinded to groups. 3 Epiretinal membrane. Intervention 1: Intervention group: patients with idiopathic ERM who underwent pars plana vitrectomy and membrane peeling with intravitreal injection of triamcinolone acetonide (IVTA). Intervention 2: Control group: patients with idiopathic ERM who underwent pars plana vitrectomy and membrane peeling without intravitreal injection of triamcinolone acetonide (IVTA). Yes - There is a plan to make this available What will be shared: IPD collected for the primary outcome measure only are to be shared When: starting 6 months after publication To whom: available for people working in academic institutions Conditions: meta-analysis or references Where to obtain: namvar.e@gmail.com How to obtain: email Comments:
public Ehsan Namvar
Khalili street
Shiraz Iran (Islamic Republic of) 7193616641 +98 71 3629 1470 Namvar.e@gmail.com Shiraz University of Medical Sciences scientific Ehsan Namvar
Khalili street
Shiraz Iran (Islamic Republic of) 7193616641 +98 71 3629 1470 Namvar.e@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with idiopathic epiretinal membrane (ERM) Decreased vision(BCVA:20/400-20/40) or metamorphopsia Central foveal thickness more than 320 micron 50 years 80 years Both Previous retinal surgery, retinal detachment, Age related macular degeneration, diabetic retinopathy, retinal vascular occlusion, uveitis vitreous hemorrhage, trauma ocular tumors, glaucoma optic atrophy, fibrotic epiretinal membrane, macular pathologies other than ERM, significant cataract corneal opacity incomplete chart records. H35.379 Puckering of macula, unspecified eye Treatment - Surgery Treatment - Drugs Intervention group: patients with idiopathic ERM who underwent pars plana vitrectomy and membrane peeling with intravitreal injection of triamcinolone acetonide (IVTA). Control group: patients with idiopathic ERM who underwent pars plana vitrectomy and membrane peeling without intravitreal injection of triamcinolone acetonide (IVTA). Central subfield thickness. Timepoint: before operation and 1, 3, 6 and 12 months after operation. Method of measurement: macular OCT. Best corrected visual acuity. Timepoint: before operation and 1, 3, 6 and 12 months after operation. Method of measurement: snellen chart. Retinal sublayers. Timepoint: before operation and 1, 3, 6 and 12 months after operation. Method of measurement: optical coherence tomography. Intraocular pressure. Timepoint: before operation and 1, 3, 6 and 12 months after operation. Method of measurement: Tonometry. Shiraz University of Medical Sciences Approved 2021-10-11 Ethics committee of Shiraz University of Medical Sciences Khalili street shiraz Fars Iran (Islamic Republic of)