Microperimetry (MP) and multifocal electroretinogram (mfERG) parameters prior to and following intravitreal injections of bevacizumab in cases of treatment-naïve center-involving diabetic macular edema (CI-DME): A prospective longitudinal observational analysis. - NI

All India Institute of Medical Sciences AIIMS0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•1.Either gender & Age: 18 – 80 years
•2.Diagnosed with treatment naïve CI-DME: (No prior treatment for DME with either of the following: intravitreal steroids, intravitreal anti-VEGFs, laser photocoagulation, vitrectomy, etc.)
•3.Patients with the VA of 6/12 (20/60, 0.5) or less will be included in the study.
•4.Patients with the central retinal thickening present in the cross-sectional SD-OCT of more than or equal to 320 µm in men and more than or equal to 305 µm in women (done on Heidelberg Engineering SPECTRALIS HRA+OCT, Heidelberg Engineering, Inc. 10 Forge Parkway Franklin, MA 02038) due to CI-DME will be included in the study.
•5.Media clarity, pupillary dilatation and subjects’ co-operation sufficient for fundus imaging (OCT), BCVA, microperimetry, and multifocal ERG testing will be included in the study.
•6.Only patients who are willing to participate in the study would be selected.

•1.Patients with previously treated NCI-DME, CI-DME or proliferative diabetic retinopathy (PDR), or any other type of macular edema such as edema secondary to retinal vascular occlusions (RVO), Irvine-Gass syndrome, etc.
•2.Patients with other associated retinal problems such as; vascular occlusions, age related macular degeneration (AMD), myopic degeneration, etc.
•3.Any other ocular condition that might affect macular edema or alter visual acuity during the study such as; vitreomacular traction (VMT), etc.
•4.Patients suffering from a significant cataract.
•5.Patients on anti-glaucoma medication.
•6.Pregnancy and breastfeeding.
•7.Any active periocular or intraocular infection / inflammation (e.g., keratitis, scleritis, uveitis).
•8.Patients not willing to participate in the study.

发起方

All India Institute of Medical Sciences AIIMS