Vitrectomy Retinal Oxygenation

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Statusas

Rėmėjai

Stefan Sacu

KLINIKINIS TYRIMAS: NCT01510691

BioSeek: nct01510691

Raktažodžiai

Santrauka

Vitrectomy is the common treatment for patients with macular edema secondary to epiretinal membrane. Recently, in eyes with diabetic macular edema or persistent macular edema following retinal vein occlusion, vitrectomy will be increasingly performed as an additional treatment modality. In eyes with impaired oxygen situation vitrectomy may improve the retinal oxygen saturation. However, little information is available about the oxygenation and the blood flow of the retinal vessels after vitroretinal surgery.

Hypoxia is a the major trigger of vascular endothelial growth factor (VEGF), which is in turn the most important factor for the development of macular edema. It is a major issue to improve the oxygen situation and the blood flow of the retina and there are just a few not satisfactory procedures available to overcome this problem. However, vitrectomy would be an adequate therapy for many of these diseases, and it would be an appreciated side effect of the treatment in almost every case.

To investigate the influence of oxygenation and blood flow of the retina on clinical outcomes after a successfully 23 gauge vitrectomy in eyes with epiretinal membrane, persistent macular edema following diabetic retinopathy or retinal vein occlusion.

Datos

Paskutinį kartą patikrinta:	05/31/2020
Pirmasis pateikimas:	01/10/2012
Numatytas registravimas pateiktas:	01/12/2012
Pirmas paskelbtas:	01/15/2012
Paskutinis atnaujinimas pateiktas:	06/24/2020
Paskutinis atnaujinimas paskelbtas:	06/28/2020
Faktinė studijų pradžios data:	09/30/2011
Numatoma pirminio užbaigimo data:	02/28/2015
Numatoma studijų užbaigimo data:	02/28/2015

Būklė ar liga

Diabetic Macular Edema

Fazė

Rankų grupės

Ranka	Intervencija / gydymas
Epiretinal membrane
diabetic macular edema
vein occlusion

Tinkamumo kriterijai

Amžius, tinkami studijuoti	18 Years Į 18 Years
Tinkamos studijoms lytys	All
Mėginių ėmimo metodas	Non-Probability Sample
Priima sveikus savanorius	Taip
Kriterijai	Inclusion Criteria: - male or female, at least 18 years of age. - ophthalmoscopic evidence of epiretinal membrane scheduled for vitrectomy and membrane peeling. - persistent diabetic macular edema - written informed consent - female patients of childbearing potential must have a negative urine pregnancy test. Exclusion Criteria: - uncontrolled systemic disease - symptoms of a clinically relevant illness in the 3 weeks before the first study day - any ocular condition that in the opinion of the investigator would be a contraindication for the surgical procedure - history of glaucoma, aphakie or presence of anterior chamber intraocular lens, choroidal neovascularisation, significant cataract, any ocular infection, - history of pars plana vitrectomy. - contraindication to pupil dilation. - need for silicon oil or gas after the surgery - advanced diabetic retinopathy with vitreoretinal tear and/or bleeding

Rezultatas

Pirminės rezultatų priemonės

1. Clinical Data [6 months]

Visus, OCT

2. Blood Flow Data [6 months]

Oxygenation of retinal blood vessles and retinal blood flow

Vitrectomy Retinal Oxygenation

Raktažodžiai

hypoxia

edema

diabetic retinopathy

epiretinal membrane

retinal vein occlusion