Glaucoma Intensity Treatment Study – Intensive non-invasive glaucoma treatment vs conventional stepwise treatment – a prospective, randomized phase IV study of disease progression in glaucoma

Phase 1

Active, not recruiting

Conditions: Glaucoma, open-angle and PEX glaucoma
MedDRA version: 20.0Level: LLTClassification code: 10030856Term: Open-angle glaucoma Class: 10015919
MedDRA version: 20.0Level: LLTClassification code: 10037118Term: Pseudoexfoliation glaucoma Class: 10015919
Therapeutic area: Phenomena and Processes [G] - Ocular Physiological Phenomena [G14]

Registration Number: CTIS2023-510041-16-00

Lead Sponsor: Region Vaesterbotten

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

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 Criteria

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.