Tokyo, May 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061684) titled 'Association Between Glycemic Variability and the Risk of Glaucoma Progression in Patients with Diabetes' on May 30.
Study Type:
Observational
Primary Sponsor:
Institute - Nagoya University Hospital
Condition:
Condition - Diabetes
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine whether hypoglycemic episodes are associated with subsequent glaucoma progression in patients with diabetes and glaucoma.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients aged 20 years or older with diabetes who have been prescribed insulin or sulfonylureas and have a diagnosis of glaucoma.
Key exclusion criteria - 1) Patients with glaucoma diagnoses other than those specified above Applicable diagnostic codes: H40.0, H40.2, H40.3, H40.4, H40.5, H40.6, H40.8, H40.9, H42
2) Patients with comorbid diseases that may cause severe visual impairment and influence the decision to perform surgery, or diseases that may increase the frequency of medical visits and thereby contribute to surveillance bias, including age-related macular degeneration, proliferative diabetic retinopathy, diabetic macular edema, cystoid macular edema, retinal vascular occlusion, retinal detachment, macular hole, optic neuritis, and uveitis
Applicable diagnostic codes: H35.3, H34.8, H33, H35.81, H43.1, H35.34, H20, H30, H17, H46, H47
3) Patients who have previously undergone retinal photocoagulation, intravitreal injection, or vitrectomy
Procedure codes: K277, K280, K282
4) Patients with a total available data period of less than 6 years, including both the landmark period and the window period
5) Patients with missing information required to ascertain the primary outcome
Target Size - 10000
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 01 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070431
Disclaimer: Curated by HT Syndication.