Status:
ACTIVE_NOT_RECRUITING
Safety of Topical Insulin Drops for Open-angle Glaucoma
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Glaucoma, a leading cause of irreversible blindness worldwide, is characterized by a permanent loss of retinal ganglion cells (RGCs), a group of central nervous system (CNS) neurons that convey visual...
Detailed Description
Glaucoma: a major health care challenge of the 21st century Glaucoma is a leading cause of irreversible blindness worldwide and is expected to affect 76 million people by the year 2020. In glaucoma, ...
Eligibility Criteria
Inclusion
- \* 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).
- 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
- 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
Key Trial Info
Start Date :
March 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04118920
Start Date
March 27 2023
End Date
December 1 2024
Last Update
August 21 2024
Active Locations (1)
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1
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 3E4