Vitrectomy Retinal Oxygenation

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Вход / Регистрация

Линкът е запазен в клипборда

Състояние

Спонсори

Stefan Sacu

КЛИНИЧНО ИЗСЛЕДВАНЕ: NCT01510691

BioSeek: nct01510691

Ключови думи

Резюме

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.

Дати

Последна проверка:	05/31/2020
Първо изпратено:	01/10/2012
Очаквано записване подадено:	01/12/2012
Първо публикувано:	01/15/2012
Изпратена последна актуализация:	06/24/2020
Последна актуализация публикувана:	06/28/2020
Действителна начална дата на проучването:	09/30/2011
Приблизителна дата на първично завършване:	02/28/2015
Очаквана дата на завършване на проучването:	02/28/2015

Състояние или заболяване

Diabetic Macular Edema

Фаза

Групи за ръце

Arm	Интервенция / лечение
Epiretinal membrane
diabetic macular edema
vein occlusion

Критерии за допустимост

Възрасти, отговарящи на условията за проучване	18 Years Да се 18 Years
Полове, допустими за проучване	All
Метод за вземане на проби	Non-Probability Sample
Приема здрави доброволци	Да
Критерии	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

Резултат

Първични изходни мерки

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

Ключови думи

хипоксия

оток

диабетна ретинопатия

epiretinal membrane

retinal vein occlusion