Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT04118920
Eligibility Criteria:
\* Please note that this study is only open to patients who are Quebec residents and who are already followed at the Centre Hospitalier de l'Université de Montréal (CHUM).
Inclusion Criteria:
* Age 18-75 years
* Capable to provide informed consent
* Diagnosed of moderate primary open-angle glaucoma
* Moderate glaucoma is defined as:
* Vertical cup-to-disc ratio of 0.7-0.85 and (or)
* Moderate VF defect not within 10° of fixation (e.g. mean deviation (MD) from -6 to -12 dB on Humphrey Visual Field 24-2)
* Only one eye per patient will be selected as the study eye - if both eyes meet the inclusion criteria, the eye with the worse acuity and/or visual field will be selected. The contralateral eye will be left untouched.
* Patients with non-restrictive diets (see exclusion criteria for a list of diets considered restrictive).
* Normal serum potassium level (3.5-5.0mEq/L or 3.5-5.0 mMol/L) and HbA1C (≤5.7%) at baseline.
Exclusion Criteria:
* Younger than 18 years of age or older than 75 years of age
* Pregnant or breastfeeding woman
* Presence of any ocular pathologies other than glaucoma that contributes to the severe vision loss (retinopathy/maculopathy, non-glaucomatous optic neuropathy, severe uveitis, keratopathy, etc.)
* History of cataract surgery (complicated or uncomplicated) within 3 months of the study
* Any other intraocular surgery within 6 months of the initiation of the study
* Visual acuity of no light perception (NLP)
* Unable to provide informed consent
* Unable to complete the tests and follow-ups required by the study
* Diagnosis of glucose intolerance, type 1 or 2 diabetes mellitus (HbA1C \> 5.7%26)
* Diagnosis of conditions leading to baseline increased risk of hypokalemia and hypoglycemia such as:
* Chronic kidney disease (with or without dialysis)
* Cardiovascular disease, history of arrythmias
* Cirrhosis or other inflammatory liver diseases (hepatitis B and C)
* Inflammatory bowel disease
* Active or chronic infections causing potassium wasting: HIV, tuberculosis, hepatitis, and sepsis as a result of these infections
* Metabolic disorders predisposing to hypokalemia such as: renal tubular acidosis, primary hyperaldosteronism, Cushing's disease
* Potomania or other alcohol abuse
* Hyperhidrosis
* Polyuria
* Nephropathies such as tubulointerstitial diseases or tubular injuries causing salt-wasting
* Any hematologic or inflammatory conditions requiring plasmapheresis
* Any known insulin-secreting tumors
* Patients with restrictive diets
* Patients at risk of malnutrition due to disability limiting daily dietary intake of nutrients and electrolytes ("tea-and-toast diet")
* Veganism
* Medically recommended low-potassium diet (such as chronic kidney disease)
* Eating disorders with risks of malnutrition, such as anorexia nervosa and bulimia
* Use of medications predisposing a patient to the risk of hypokalemia such as high dose diuretics and laxatives
* History of hypersensitivity to insulin or any of the ingredients in the formulation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04118920
Study Brief:
Protocol Section:
NCT04118920