Glaucoma Intensity Treatment Study – Intensive non-invasive glaucoma treatment vs conventional stepwise treatment – a prospective, randomized phase IV study of disease progression in glaucoma (GITS Main Study and Extension). - GITS

Region Västerbotten0 个研究点目标入组 240 人开始时间: 2013年8月7日最近更新: 2024年5月21日

适应症

试验速览

暂无简介。

•Newly diagnosed open-angle glaucoma (incl. normal pressure glaucoma) or PEX glaucoma in one or both eyes (both eyes can be included as study eyes if they fulfill the criteria of inclusion/exclusion).
•VFI (Visual Field Index)=65%, applicable for both eyes even if only one eye will be included.
•Patient should be previously untreated with intraocular pressure lowering medication.
•Age: 40-78 years at time of inclusion.
•Additional inclusion criteria for GITS extension
•Completed the GITS Main study in Umeå
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•Pregnant or breast feeding women or women in childbearing potential not using acceptable contraceptive method.
•Patients with contraindications to the glaucoma medicine to be given.
•If there is any obstacle for performing the LTP.
•Disease or condition that probably prohibits long-term follow-up.
•Intraocular surgery except uncomplicated cataract operation.
•Diabetes with proliferative retionopathy or serious non-proliferative retionopathy [(intra-retinal bleedings, pronounced intra-retinal microvasculation, ”definite venous beading” macular edema with hard exudates that reach fovea according to International Clinical Diabetic Retionopathy and Macular Edema Disease Severity scales (Wilkinson et al 2003)].
•Neurological and other non-glaucoma conditions, except cataract, that can affect the vision.

发起方