Clinical Trial: Investigation of Morphological Changes in Corneal Sensory Nerves and Their Effects on Corneal Perception and Pain in Dry Eye (Japan)

Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063108) titled 'Investigation of Morphological Changes in Corneal Sensory Nerves and Their Effects on Corneal Perception and Pain in Dry Eye' on Sept. 30.

Study Type: Observational

Primary Sponsor: Institute - Hiroshima University

Condition: Condition - dry eye Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this cross-sectional study is to evaluate corneal sensory nerve morphology, corneal sensation and pain, tear film break-up time (TFBUT), and other subjective and objective findings related to dry eye disease in three populations: healthy adults, asymptomatic individuals with shortened TFBUT (TFBUT-shortened subjects), and patients diagnosed with dry eye disease. Through comparative assessment across these groups, the study aims to exploratorily identify characteristic morphological changes in corneal sensory nerves associated with the progression of dry eye disease and to clarify the influence of these morphological changes on corneal sensory function and pain perception. Basic objectives2 - Bio-equivalence

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Subjects aged 18 years or older at the time of providing informed consent Subjects who are capable of providing written informed consent of their own free will Key exclusion criteria - Subjects with comorbid or past ocular diseases other than dry eye that affect the ocular surface, corneal sensation/pain, or nerve morphology evaluation Subjects with a history of corneal surgery, cataract surgery, LASIK, corneal transplantation, or other ocular surgeries Subjects with comorbid or past diabetes mellitus or other systemic diseases affecting the nervous system Subjects who are otherwise judged inappropriate for participation by the principal investigator or sub-investigator Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 30 Day Anticipated trial start date - 2027 Year 01 Month 01 Day Last follow-up date - 2027 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072235

Disclaimer: Curated by HT Syndication.