Glaucoma Intensity Treatment Study – Intensive non-invasive glaucoma treatment vs conventional stepwise treatment – a prospective, randomized phase IV study of disease progression in glaucoma
Key facts
- Where
- Umea, SvédországSee the site
- Phase
- 4. fázis
Where in Svédország
- Region VaesterbottenUmea, SvédországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Vaesterbotten
- Trial code
- EU 2023-510041-16-00
- Record updated
- 2024. május 16.
- Original description
To compare the perimetric rate of progression with two types of initial treatment; mono drop therapy and combo drop therapy + third medication + LTP 360° on patients with newly diagnosed open-angle glaucoma, definied as confirmed vision loss with papill/nerve fibre damage.Read full original descriptionShow less
To compare the perimetric rate of progression with two types of initial treatment; mono drop therapy and combo drop therapy + third medication + LTP 360° on patients with newly diagnosed open-angle glaucoma, definied as confirmed vision loss with papill/nerve fibre damage.
Inclusion: 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.
Exclusion: Intraocular surgery except uncomplicated cataract operation; Disease or condition that probably prohibits long-term follow-up; 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; 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.