An observational study in Diabetic Macular Edema, sponsored by Rehab Azzam. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Rehab Azzam · Observational
Diabetic retinopathy (DR) is one of the leading causes of vision loss worldwide [1]. In 2010, DR affected more than 93 million individuals worldwide, 28 million of whom experienced vision-threatening DR[2].
Diabetic macular edema (DME) is a common cause of visual loss in diabetic retinopathy (DR) and is a complication in any stages of DR including proliferative diabetic retinopathy (PDR)[3].
The terms vitreous traction maculopathy, vitreous induced diabetic macular edema and maculopathy due to posterior hyaloid traction are synonymous and describe a pattern of diabetic maculopathy which is characterized by: (1) The absence of complete posterior vitreous detachment; (2) An increased retinal thickness in the center of the macula, and (3) a characteristic reflex of the vitreoretinal interface[4]. there are multiple factors in the vitreomacular interface including ERM, taut posterior cortices, vitreoschisis, PVD, and adhesions [5]. Anomalous PVD generates antero-posterior and tangential traction forces at the vitreo-retinal interface that act upon the inner and outer retinal layers [6]. Until recently, the only treatment option available for VMA was vitrectomy[7].
Few studies have used the multifocal electroretinogram (mfERG) technique to investigate the effects of vitrectomy on macular visual function for DME [8]. Mf-ERG is an objective electrophysiologic technique that measures the electrical changes in the central retinal area. This technique accurately assess the electrophysiologic activity in multiple retinal areas, and gives us a topographic charting of retinal function [9] .
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's planned enrollment of 21 is below the median of 97 across 163 observational studies indexed under Macular Edema.
Browse Macular Edema studies →This is the only study on the registry with Rehab Azzam as lead sponsor.
Counted across the registry records on this site, refreshed daily.
eyes with tractional diabetic macular edema
Exclusion Criteria:
pars plana vitrectomy
assessment the outcomes of vitrectomy on retinal function in patients with tractional diabetic macular edema
assessment the outcomes of vitrectomy on retinal function by mf-ERG (multifocal electroretinogram) in patients with tractional diabetic macular edema
Time frame: baseline
assessment the outcomes of vitrectomy on retinal anatomy in patients with tractional diabetic macular edema
assessment the outcomes of vitrectomy on retinal anatomy by OCT (optical coherence tomography) in patients with tractional diabetic macular edema
Time frame: Baseline
correlation CDVA with mf-ERG and OCT finding
To correlate the postoperative corrected distance visual acuity (CDVA) with the mf-ERG and OCT findings following vitrectomy surgery for TDME.
Time frame: baseline
No study locations are listed for this record.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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