Diabetic Macular Edema
Conditions
Brief summary
1. assessment the outcomes of vitrectomy on retinal function by mf-ERG (multifocal electroretinogram) and anatomy by OCT (optical coherence tomography) in patients with tractional diabetic macular edema (TDME) . 2. To correlate the postoperative corrected distance visual acuity (CDVA) with the mf-ERG and OCT findings following vitrectomy surgery for TDME.
Detailed description
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 \[9\] .
Interventions
PROCEDUREvitrectomy
pars plana vitrectomy
Sponsors
Rehab Azzam
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years; type 1 or 2 diabetes * TDME as the indication for vitrectomy; central foveal thickness (CFT) ≥300 µm as measured by spectral-domain optical coherence tomography (SD-OCT) , We defined VMIA on OCT as ERM, anomalous vitreomacular adhesions, or both , ), and possible visual acuity impairment attributed to foveal thickening due to DME.
Exclusion criteria
* A history of other retinal diseases; or active ocular inflammation or infection or glaucoma . * Eyes with macular edema from etiologies other than diabetes * Dense refractive media opacity before and after surgery, such as dense cataract, vitreous hemorrhage which can conceal fundus visualization and OCT measurements * Central retinal ischemia detected by intravenous fluorescein angiograms. * A history of vitrectomy * A visual acuity worse than 1\\60 and the duration of tractional ERM is more than 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assessment the outcomes of vitrectomy on retinal function in patients with tractional diabetic macular edema | baseline | assessment the outcomes of vitrectomy on retinal function by mf-ERG (multifocal electroretinogram) in patients with tractional diabetic macular edema |
| assessment the outcomes of vitrectomy on retinal anatomy in patients with tractional diabetic macular edema | Baseline | assessment the outcomes of vitrectomy on retinal anatomy by OCT (optical coherence tomography) in patients with tractional diabetic macular edema |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| correlation CDVA with mf-ERG and OCT finding | baseline | To correlate the postoperative corrected distance visual acuity (CDVA) with the mf-ERG and OCT findings following vitrectomy surgery for TDME. |
Contacts
Primary Contactrehab azzam, master
Outcome results
None listed