Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316388
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-09
Brief Title:
Outcomes After Vitrectomy in Eyes With Tractional Diabetic Macular Edema
Sponsor:
Rehab Azzam
Organization:
Assiut University
Study Overview
Official Title:
Anatomical and Functional Outcomes After Vitrectomy in Eyes With Tractional Diabetic Macular Edema
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 DR2
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 PDR3
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 interface4 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 vitrectomy7
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
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 PDR3
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 interface4 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 vitrectomy7
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None