Tokyo, Oct. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063351) titled 'Changes in Aqueous Humor Outflow Facility Following Ripasudil Eye Drop Treatment' on Oct. 22.
Study Type:
Observational
Primary Sponsor:
Institute - University of Toyama
Condition:
Condition - Primary open-angle glaucoma (including normal-tension glaucoma)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to evaluate longitudinal changes in aqueous humor outflow facility (C-value) before and after initiation of ripasudil eye drops in patients with primary open-angle glaucoma, including normal-tension glaucoma, and to investigate the association between changes in outflow facility and intraocular pressure reduction.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients diagnosed with primary open-angle glaucoma or normal-tension glaucoma at the Department of Ophthalmology, Toyama University Hospital.
2. Patients for whom initiation of ripasudil eye drops has been decided as part of routine clinical care.
3. Patients aged 20 years or older.
4. Patients who can undergo intraocular pressure measurement using Goldmann applanation tonometry and aqueous humor outflow facility (C-value) measurement using a pneumatonometer.
5. Patients who have provided voluntary written informed consent after receiving sufficient information about the study.
Key exclusion criteria - 1. History of glaucoma surgery.
2. History of laser trabeculoplasty.
3. History of cyclophotocoagulation.
4. Corneal disease or corneal opacity that interferes with intraocular pressure measurement using Goldmann applanation tonometry or aqueous humor outflow facility (C-value) measurement using a pneumatonometer.
5. History of hypersensitivity to ripasudil eye drops.
6. Patients considered unsuitable by the principal investigator or study investigators because of severe systemic disease, ocular comorbidities, inability to maintain a supine position during examination, or other conditions that may interfere with safe C-value measurement or completion of scheduled study assessments.
7. Patients with severe corneal epithelial damage that may be aggravated by tonography.
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 10 Month 08 Day
Date of IRB - 2026 Year 10 Month 08 Day
Anticipated trial start date - 2026 Year 11 Month 01 Day
Last follow-up date - 2029 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072509
Disclaimer: Curated by HT Syndication.