NCT06316388

Outcomes After Vitrectomy in Eyes With Tractional Diabetic Macular Edema

Anatomical and Functional Outcomes After Vitrectomy in Eyes With Tractional Diabetic Macular Edema

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 21 (estimated)
• Sponsor: Rehab Azzam · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 \[9\] .

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
PROCEDURE	vitrectomy	pars plana vitrectomy

Timeline

• Start date: 2024-03-10
• Primary completion: 2025-03-10
• Completion: 2025-03-11
• First posted: 2024-03-18
• Last updated: 2024-03-18