Tokyo, July 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062332) titled 'A Study on the Efficacy and Safety of Scleral Lens Fitting in Relation to Palpebral Fissure Width' on July 30.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Tokushima University

Condition: Condition - Healthy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - By having healthy adults wear scleral lenses and evaluating changes in palpebral fissure width before and after lens wear as the primary endpoint, we will investigate the effect of scleral lens wear on palpebral fissure widening, thereby obtaining basic findings that will contribute to future clinical applications and trial design. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - In this study, scleral lenses will be fitted to both eyes of healthy adults. The lenses will be appropriately selected and fitted according to the shape of each subject's cornea and inserted while filled with sterile saline solution. Insertion will be performed under the supervision of an ophthalmologist or a sufficiently trained healthcare professional. Wearing time will be kept to the minimum necessary for evaluation, and palpebral width measurements and ophthalmic examinations will be performed before and after lens insertion.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Healthy adults aged 20 or older at the time of obtaining informed consent Individuals with no notable abnormalities in their ophthalmic history (regardless of whether they wear corrective lenses, but who do not have any active diseases) Individuals deemed capable of wearing scleral lenses and undergoing various examinations in one or both eyes Individuals who have received a thorough explanation of the study and have provided written informed consent Key exclusion criteria - Individuals with corneal disorders (such as corneal epithelial disorders, keratitis, or keratoconus) Individuals with active ocular infections or inflammatory conditions (such as conjunctivitis or blepharitis) Individuals for whom it is determined that wearing scleral lenses could worsen symptoms, such as those with severe dry eye Individuals for whom proper evaluation is difficult due to eyelid abnormalities (severe ptosis, lagophthalmos, blepharospasm, etc.) Individuals with a known history of intolerance or allergy to contact lenses Any other individuals deemed unsuitable for participation in this study by the principal investigator or co-investigators Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 24 Day Anticipated trial start date - 2026 Year 10 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=R000071155

Disclaimer: Curated by HT Syndication.