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

Authors
Category Primary study
Registry of TrialsClinical Trials Information System
Year 2024
INTERVENTION: Product Code: SCP130905,Pharmaceutical Form: ,Other descriptive name: ,Product Code: SCP13242439,Pharmaceutical Form: ,Other descriptive name: ,Product Code: SCP142924,Pharmaceutical Form: ,Other descriptive name: ,Product Code: SCP12507528,Pharmaceutical Form: ,Other descriptive name: ,Product Code: SCP158236,Pharmaceutical Form: ,Other descriptive name: ,Product Code: SCP174719,Pharmaceutical Form: ,Other descriptive name: ,Product Code: SCP129633,Pharmaceutical Form: ,Other descriptive name: ,Product Code: SCP12535123,Pharmaceutical Form: ,Other descriptive name: ,Product Code: SCP253570,Pharmaceutical Form: ,Other descriptive name: ,Product Code: SCP12651926,Pharmaceutical Form: ,Other descriptive name: ,Product Code: SCP16877661,Pharmaceutical Form: ,Other descriptive name: ,Product Code: SCP150127,Pharmaceutical Form: ,Other descriptive name: CONDITION: Glaucoma, open‐angle and PE Xglaucoma ; MedDRA version: 20.0Level: LLTClassification code: 10037118Term: Pseudoexfoliation glaucomaSystem Organ Class: 10015919 ; MedDRA version: 20.0Level: LLTClassification code: 10030856Term: Open‐angle glaucomaSystem Organ Class: 10015919 MedDRA version: 20.0Level: LLTClassification code: 10030856Term: Open‐angle glaucomaSystem Organ Class: 10015919 MedDRA version: 20.0Level: LLTClassification code: 10037118Term: Pseudoexfoliation glaucomaSystem Organ Class: 10015919 Therapeutic area: Phenomena and Processes [G] ‐ Ocular Physiological Phenomena [G14] PRIMARY OUTCOME: Main Objective: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. Primary end point(s):Rate of progression, the aim of the study is to compare and follow‐up the patients on traditional clinical treatment with those receiving more intensive treatment, and measure the rate of progression as long as possible. Secondary Objective:To monitor the effect of adherence for rate of progression.,To identify factors at early diagnosis that can effect the rate of progression: Single subject – age, heredity, sex, origin, other diseases, medication, blood pressure. Life style– smoking, BMI, alcohol use, coffee drinking, diet, physical activity Eyes– eye pressure, PEX , refraction, corneal thickness measured with Scheimflug‐kamera (Pentacam, Oculus), OCT‐techniques (spectral domain optical coherence tomography with enhanced depth imaging).,To measure correlation between structure and function during disease progression by examining the nerve fibre layer and ganglion cell layer with spectral domain optical coherence tomography (SD‐OCT). Standard Automated Perimetry (SAP) with Humphrey Field Analyser (Carl Zeiss Meditec).,To measure Quality of Lite for randomised patients at one month visit and after 3, 5, 8 and 10 years; QoL in relation to treatment alternative and rate of progression. SECONDARY OUTCOME: Secondary end point(s):Compliance and adherence Secondary end point(s):Quality of life INCLUSION CRITERIA: Newly diagnosed open‐angle glaucoma (incl. normal pressure glaucoma) or PE Xglaucoma 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.
Epistemonikos ID: 87bfa64960461c00f60037b8565d56a3b8f26892
First added on: Aug 28, 2024