Tokyo, May 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061563) titled 'A Study on the Relationship Between Keratoconus Severity, Age, and Corneal Stiffness' on May 14.
Study Type:
Observational
Primary Sponsor:
Institute - Keio University School of Medicine
Condition:
Condition - Keratoconus
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Measure corneal stiffness (Brillouin values) in normal eyes and keratoconic eyes, categorized by age, disease stage, and pre- vs. post-corneal cross-linking status.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 8
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Patients who visited the Keratoconus Clinic in the Department of Ophthalmology at Keio University Hospital.
2) Individuals who provide written informed consent to participate in this study.
3) Age: 8 years or older (no upper age limit).
Key exclusion criteria - 1) Ocular diseases potentially affecting corneal stiffness (e.g., severe dry eye, corneal scarring, inflammatory corneal disease, bullous keratopathy).
2) History of corneal surgery other than corneal cross-linking.
3) Patients with photosensitivity.
4) Pediatric subjects unable to read or understand the assent form.
5) Individuals deemed unsuitable for participation by the Principal Investigator or Sub-investigator.
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 03 Month 17 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070441
Disclaimer: Curated by HT Syndication.
