Treatment of glaucoma (eye disease) - Prospective study where the effect of intensive treatment with eye drops and laser is compared to conventional stepwise increase of treatment.
- Conditions
- Glaucoma, open-angle and PEX glaucoma.MedDRA version: 20.0Level: LLTClassification code 10030856Term: Open-angle glaucomaSystem Organ Class: 100000004853MedDRA version: 20.0Level: LLTClassification code 10037118Term: Pseudoexfoliation glaucomaSystem Organ Class: 100000004853Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]
- Registration Number
- EUCTR2013-002895-42-SE
- Lead Sponsor
- Region Västerbotten
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method