]>
IRCT20200312046750N1 IRCT 2020-03-26 University of Medicine and Pharmacy ,,Iuliu Hatieganu" Vitrectomy for diabetic vitreous hemorrhage Visual outcomes and prognostic factors following pars plana vitrectomy for vitreous haemorrhage in patients with diabetic retinopathy 2012-01-01 anticipated 130 Complete https://irct.ir/trial/46511 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Diabetic retinopathy. Intervention consisted in pars plana vitrectomy (removal of the vitreous body). If needed, retinal endolaser (panretinal photocoagulation PRP or laser completion) was performed. Phacoemulsification with intraocular lens insertion and PPV were combined when the lens opacification prevented the visualization of the posterior segment. At the end of surgery, the vitreous cavity was left under Ballance Salt Solution (BSS), air or silicone oil 1000cSt. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because of the confidentiality of the information
public Ioana Damian
No.8 Victor Babes
Cluj-Napoca Romania 400012 +40 264 597 256 ioana.damian@umfcluj.ro ,,Iuliu Hatieganu" University of Medicine and Pharmacy scientific Ioana Damian
No.8 Victor Babes
Cluj-Napoca Romania 400012 +40 264 597 256 ioana.damian@umfcluj.ro ,,Iuliu Hatieganu" University of Medicine and Pharmacy Romania Non clearing vitreous hemorrhage for more than a month Severe diabetic retinopathy Treatment: pars plana vitrectomy Single surgeon experience no limit no limit Both Follow-up less than 3 months Other macular diseases, advanced glaucoma History of ocular trauma History of pars plana vitrectomy for tractional retinal detachment E08.35 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy Treatment - Surgery Intervention consisted in pars plana vitrectomy (removal of the vitreous body). If needed, retinal endolaser (panretinal photocoagulation PRP or laser completion) was performed. Phacoemulsification with intraocular lens insertion and PPV were combined when the lens opacification prevented the visualization of the posterior segment. At the end of surgery, the vitreous cavity was left under Ballance Salt Solution (BSS), air or silicone oil 1000cSt Postoperative best corrected visual acuity(BCVA). Timepoint: 3 months after pars plana vitrectomy. Method of measurement: Measurement of the visual acuity using Snellen chart. Frequency of postoperative early and late vitreous hemorrhage. Timepoint: Early onset: < 4 weeks and late onset > 4 weeks. Method of measurement: Slit lamp and ophthalmoscopy. University of Medicine and Pharmacy ,,Iuliu Hatieganu" Approved 2020-03-24 Ethics Committee of the "Iuliu Hatieganu" University of Medicine and Pharmacy No.8, Victor Babes Cluj-Napoca Cluj Romania